TRIGEN® IM NAIL SYSTEM SURGICAL TECHNIQUE

TRIGEN IM NAIL SYSTEM
SURGICAL TECHNIQUE
®
Trochanteric Antegrade Nail (TAN™)
As Described By
Thomas A. Russell, M.D.
and
Roy W. Sanders, M.D.
Nota Bene: The technique description herein is made available to the healthcare professional to
illustrate the authors’ suggested treatment for the uncomplicated procedure. In the final analysis,
the preferred treatment is that which addresses the needs of the patient.
WARNING: This device is not approved for screw attachment
or fixation to the posterior elements (pedicles) of the
cervical, thoracic, or lumbar spine.
TROCHANTERIC ANTEGRADE SURGICAL TECHNIQUE FOR STANDARD FEMORAL OR RECON LOCKING MODES
PATIENT PREPARATION
1 Patient is placed supine with unaffected limb
extended below the affected limb and trunk. The
affected limb is adducted. Flex the affected hip
15°–30°. Apply traction through a skeletal pin or the
foot with the fracture table foot holder. Adjust the
affected limb for length and rotation by comparison
with the unaffected limb. Rotation is further checked
by rotating the arm to align the femoral neck anteversion and then making the appropriate correction by
foot, usually in 0°–15° of external rotation. This is best
checked by visualizing the femoral anteversion proximally and matching it with correct rotation at the knee
(Figure 1A). A second option is illustrated in Figure 1B.
2 Palpate the greater trochanter. Make a 1 to 3 cm
incision proximal to the greater trochanter. Angle this
incision posteriorly at its proximal end. Carry the incision through the fascia (Figure 2).
Figure 1A
Figure 1B
Figure 2
ENTRY PORTAL
3 Assemble the Entry Tool and Honeycomb Insert
(7163-1114). The Entry Tool/Honeycomb assembly is
oriented so that the superior side of the bevel is medial
(NOTE: this requires setting the Entry Tool indicator
to “R” for a left nail and to “L” for a right nail which
is opposite to the standard FAN technique) and
advanced until it rests against the lateral aspect of the
greater trochanter. Attach suction to the Entry Tool to
assist in blood evacuation and minimize aerosolisation
of blood to operative team (Figure 3).
Figure 3
2
TROCHANTERIC ANTEGRADE SURGICAL TECHNIQUE FOR STANDARD FEMORAL OR RECON LOCKING MODES
4 Insert the 3.2 mm tip threaded guide wire
through the Honeycomb and advance 1 to 2 cm into
the cortex at the tip of the greater trochanter. The
guide wires will snap fit into the Mini-Connector
(7163-1186), which easily connects to any drill with a
“Hall” connector. Once proper placement of the guide
wire has been established, the “honeycomb” insert
should be removed (Figure 4).
Figure 4
Entry Connector
12.5 mm
Entry Reamer
Channel Reamer
Figure 5
Figure 6
5 Tighten the Entry Reamer Connector (7163-1120)
onto the 14 mm Channel Reamer (7163-1118) and
insert the 12.5 mm Entry Reamer (7163-1116) until
it “clicks” into the assembly (Figure 5). Attach the
12.5 mm Entry Reamer to power to ream the proximal
section of the femur through the Entry Tool. After
removing the first guide wire and the Honeycomb,
the Channel Reamer assembly is introduced over the
remaining wire and advanced 1 to 2 cm into bone.
The reamer assembly is then manipulated under image
guidance until the shaft axis and intended path of the
reamer form an angle of approximately 5° in the AP
view and are in line in the ML view. Caution should be
used not to overestimate the angle, as too much insertion angle of the instrument may make advancement
more difficult. Once the correct orientation is obtained,
the reamer assembly is advanced to full depth. This
reamer assembly enlarges the proximal femur 1.0 mm
over the diameter of the head of the nail to 14 mm.
Remove the 12.5 mm Entry Reamer and guide wire,
keeping the Entry Tool and 14mm Channel Reamer
in place (Figure 6).
3
TROCHANTERIC ANTEGRADE SURGICAL TECHNIQUE FOR STANDARD FEMORAL OR RECON LOCKING MODES
FRACTURE REDUCTION
6 Snap the T-Handle (7163-1172) onto the
Reducer (7163-1124) (Figure 7). Place these through
the Entry Tool and 14 mm Channel Reamer to reduce
the fracture (Figure 8). Once the Reducer is in the
medullary canal and has captured the distal fragment,
the 3.0 mm Ball-Tipped Guide Rod (7163-1126) is
inserted through the Reducer into the distal femur
in the region of the epiphyseal scar (Figure 9).
The Gripper (7163-1100) is useful in holding
onto the Guide Rod during insertion and removal
(Figure 9 Inset).
Figure 7
Figure 8
Figure 9
Figure 9 Inset
4
TROCHANTERIC ANTEGRADE SURGICAL TECHNIQUE FOR STANDARD FEMORAL OR RECON LOCKING MODES
CANAL PREPARATION
Figure 10
7 Canal preparation is dependent on surgical decision. If reaming is planned, use progressive reamers
through the Entry Tool. Unreamed nails are selected
based on preoperative planning, but should be of sufficient size to provide translational fill of the intramedullary canal in the mid-diaphysis. Once the Guide Rod
is in place, remove the Reducer but leave the 14 mm
Channel Reamer in place. Proceed to sequentially
ream the femoral shaft to .5 to 1.0 mm or more above
the chosen nail diameter through the 14 mm Channel
Reamer. For more curved femoral shafts, .5 to 1.0 mm
of over reaming may be beneficial (Figure 10). In
patients that are very tall, the Flex Reamer Extender
(7163-1130) may be added to extend the shaft of the
flexible reamer for very distal fractures or nails longer
than 42 cm. NOTE: For 13 mm nails, the 14 mm
Channel Reamer must be removed before reaming
with the 13.5 and 14 mm reamer diameters.
NAIL SELECTION
8 Determine nail diameter from image intensifier or
templating. Never insert a nail that has a larger diameter
than the last reamer used.
Figure 11
9 Position the tip of the guide rod at the desired level
of the tip of the nail considering fracture patterns and
locking screw positioning (Figure 11). Measure the
nail length by positioning the open end of the Ruler
(7163-1128) over the exposed end of the guide rod
pushing the end down to the level of bone through the
14 mm Channel Reamer. Confirm the position on the
image intensifier. The tip of the Ruler should line up
with the step on the 14 mm Channel Reamer for correct
length measurement. The end should be at the tip of the
piriforma fossa for the TAN Recon mode. Use preop
templating for correct length measurement, as excessive
countersinking may require as much as a 2 cm shorter
nail length adjustment. Read the nail length from the
calibrations exposed at the other end of the Ruler.
Leave the guide rod in place for placement of the nail.
Exchange of the ball-tipped guide rod is not necessary.
5
TROCHANTERIC ANTEGRADE SURGICAL TECHNIQUE FOR STANDARD FEMORAL OR RECON LOCKING MODES
DRILL GUIDE ASSEMBLY
FEMORAL MODE
10 Insert the Guide Bolt (7163-1136) into the Drill
Guide (7163-1134) and use the Guide Bolt Wrench
(7163-1140) to secure the bolt to the nail. Screw the
Impactor onto the top of the Drill Guide to drive the
nail into the medullary canal (Figure 12). Insert the
Skin Protector (7163-1132) in the incision parallel to
the Entry Reamer Tool. Remove the Entry Reamer Tool
and 14 mm Channel Reamer. The Skin Protector will
assist in maintaining control of the surrounding tissues
and provide continued access to the bone. Advance
the nail over the guide rod and carefully past the
fracture. As the nail is inserted, it is rotated so the bow
is pointed lateral. During advancement, the nail may
be rotated to allow proper positioning and seating of
the proximal section if needed. Due to the greater
trochanter entry point, it may be necessary to countersink the nail more than a FAN to ensure the proximal
locking screws are positioned appropriately. At this
point the standard FAN technique may be followed.
Remove the guide rod after the nail is inserted and
before inserting the locking screws (Figure 13).
Lime = Left
Rose = Right
Figure 12
Figure 13
INTERLOCKING FOR FEMORAL MODE
5.0 mm (GOLD) screws are to be used to lock the 10 mm,
11.5 mm and 13 mm TAN Implants.
11 Proximal Screw: To place screws at a 45° angle
from the greater to lesser trochanter, the following
options are available (Figure 14):
A. PREDRILLING TECHNIQUE — Make a stab incision at the entry hole and push the Gold Outer Drill
Sleeve (7163-1152) through the drill guide hole
until it is touching the lateral cortex. Introduce the
Silver Inner Drill Sleeve (7163-1156) through the
Gold Outer Drill Sleeve. Attach the Long Pilot Drill
(7163-1110) to power using the Mini-Connector
(7163-1186). The length measurements are taken
6
Figure 14
TROCHANTERIC ANTEGRADE SURGICAL TECHNIQUE FOR STANDARD FEMORAL OR RECON LOCKING MODES
Figure 15
Figure 16
Figure 17
from the calibrations off the drill in relation to the
end of the Silver Inner Drill Sleeve (Figure 15).
The appropriate length 5.0 mm screw (GOLD) is
selected and attached to the Screwdriver. The drill
and Silver Inner Drill Sleeve are removed and the
screw is inserted through the Gold Outer Drill
Sleeve. Attach Screwdriver to power or use manual
T-Handle (7163-1172) and place screw in bone. The
Screwdriver contains a laser-marked ring. This ring
should be stopped short of the Gold Outer Drill
Sleeve to prevent final seating of the screw by power.
It is recommended that final tightening of the
5.0 mm screw should always be under manual control using the T-Handle (7163-1172) (Figure 16).
B. SCREW LENGTH GAUGE — Pre-drill through both
cortices. Insert the Screw Length Gauge through the
Gold Outer Drill Sleeve (7163-1152) from the far
cortex to measure for proper 5.0 mm screw (GOLD)
length. The appropriate length 5.0 mm screw
(GOLD) is selected and attached to the Screwdriver
(Figure 17). Attach Screwdriver handle to power or
use manual T-handle (7163-1172) and place screws
in bone. The Screwdriver contains a laser-marked
ring. This ring should be stopped short of the 9 mm
Drill Sleeve to prevent final seating of the screw by
power. It is recommended that final tightening of
the 5.0 mm screw should always be under manual
control using the T-Handle (7163-1172) (Figures
18 and 19).
Figure 18
Figure 19
7
TROCHANTERIC ANTEGRADE SURGICAL TECHNIQUE FOR STANDARD FEMORAL OR RECON LOCKING MODES
DRILL GUIDE ASSEMBLY
RECON MODE (Also Applies to Trochanteric Nail)
6.4 mm (BLUE) screws are to be used to lock the 10 mm,
11.5 mm and 13 mm diameter TAN Implants proximally in
the Recon mode.
5.0 mm (GOLD) screws are to be used to distal lock
10.5 mm, 11 mm and 13 mm TAN Implants.
10 Insert the Guide Bolt (7163-1136) into the Drill
Guide (7163-1134) and use the Guide Bolt Wrench
(7163-1140) to secure the bolt to the nail. Connect
the Hip Guide (7163-1144) to the Drill Guide. The
guide is keyed so that it will only fit one way. Tighten
the knurled knob by hand until snug. Use the end of
the Guide Bolt Wrench (7163-1140) to finish tightening
the guide in place. Check the alignment of the guide
to the screw holes by passing the Medium Screwdriver
(7163-1166) through the Gold Outer Drill Sleeve
(7163-1152) up into the holes of the nail. Screw the
Impactor onto the top of the Drill Guide to drive the
nail into the medullary canal (Figure 19). Insert the
Skin Protector (7163-1132) in the incision parallel to
the Entry Reamer Tool. Remove the Entry Reamer Tool
and Channel Reamer. The Skin Protector will assist in
maintaining control of the surrounding tissues and
provide continued access to the bone. Advance the
nail over the guide rod and carefully past the fracture.
Remove the guide rod after the nail is inserted and
before inserting the locking screws (Figure 20). If
insertion is difficult, place the bow of the nail lateral and
rotate during insertion to more easily place the nail.
8
Figure 19
Figure 20
TROCHANTERIC ANTEGRADE SURGICAL TECHNIQUE FOR STANDARD FEMORAL OR RECON LOCKING MODES
INTERLOCKING FOR RECON MODE
Figure 21
Figure 22
11 PROXIMAL SCREWS: Two aspects of screw placement into the femoral head must be noted before
drilling into the femoral head. (1) Alignment of the
anteversion, and (2) Depth of nail insertion. To begin,
rotate the C-Arm proximally until a true line of the hip
is visualized, this gives the correct axis of alignment for
anteversion. Rotate the handle of the nail guide until it
bisects the femoral head in the lateral view. This
should assist in setting the correct anteversion position
of the screws. Mark this position with a skin marker on
the leg parallel to the driving handle. Next, rotate the
C-Arm into an A/P view using the calibrated notches on
the proximal attachment of the nail, which is visualized
radiographically, to determine from preoperative planning what depth of nail insertion will be required to
allow both screws to be centered in the head. As a rule,
the inferior screw is placed first, though in situations
where the neck is large enough, the proximal screw
can be placed, again, approximately 4-5 mm from the
superior cortical margin of the femoral neck. These
screws are angled at 135° in relation to the shaft. If
both screws will not seat within the femoral head, it is
probable that too much varus positioning of the proximal fragment has occurred, or the proximal nail entry
portal is too lateral (Figure 21).
A. 6.4 mm Screw Placement Technique — Make
an incision at the entry holes of the proximal screw
sleeves, and then connect the two puncture wounds
for approximately a 3 cm incision that will accommodate the insertion of both screws. Insert the
Silver Inner Drill Sleeve (1163-1156) into the Gold
Outer Drill Sleeve (7163-1152) and push to bone.
Insert the Tip Threaded Guide Pin (7163-1190) into
the Silver Inner Drill Sleeve (7163-1152) and connect to power using the Mini-Connector (71631186). Drill into the femoral neck and head to the
desired depth and position (Figure 22). Drill the
9
TROCHANTERIC ANTEGRADE SURGICAL TECHNIQUE FOR STANDARD FEMORAL OR RECON LOCKING MODES
femoral neck with the 6.4 mm Drill (7163-1160)
to slightly less than the depth desired. Check the
alignment in A/P and 15° lateral views again before
removing the 6.4 mm drill. Use the 6.4 mm Tap
(7163-1162) through the drill sleeve to prepare the
bone for screw insertion (Figure 23). Measure the
depth for the screw length from the calibrations on
the drill or tap with respect to the Gold Outer Drill
Sleeve. Attach the appropriate length 6.4 mm screw
(BLUE) to the Medium Screwdriver (7163-1166).
Attach Screwdriver handle T-Handle (7163-1172)
and insert captured screw into the inferior proximal hole, but do not tighten. Once the first screw
is inserted, do not disassemble the Screwdriver.
Repeat the procedure for the suyperior screw with
the Long Screwdriver (7163-1164) (Figures 24
and 24 Inset). Tighten the proximal screws when
the traction is released to maximize compression
at the fracture site. Once an acceptable position is
obtained, detach the Screwdriver from the screws,
proximal locking is complete (Figure 25).
Figure 23
Figure 24
Figure 24 Inset
Figure 25
10
TROCHANTERIC ANTEGRADE SURGICAL TECHNIQUE FOR STANDARD FEMORAL OR RECON LOCKING MODES
Proper Screw Measurement
ä
All TriGen locking screw measuring devices,
measure from bottom of head to the last
complete thread of screw. This is the working
length of the screw. Thus, the screw itself
is longer than the measurement and adding
length is not necessary.
Figure 26
Figure 27
12 DISTAL SCREWS FOR STANDARD TAN: Perform distal
locking with the standard TAN with the Cole Radiolucent Drill
or Freehand Technique. The Freehand technique is used with
the C-Arm placed medial to the patient, allowing for proper
image of the femur. Make adjustments to the C-Arm until perfect
circles are visualized. For the short TAN (Blue), distal locking
is performed by attaching the 8.5 mm FAN Guide (7163-1119)
with the Blue Tip for targeting the distal holes. Make a stab
incision over the holes of the image and then one of the
following techniques may be used (Figure 26).
A. Predrilling Technique — After perfect circles are confirmed, a stab incision is made over the holes. Confirm the
alignment and attach the Long Drill (7163-1110) to power
using the Mini-Connector (7163-1186). Insert the drill
through both cortices. Remove the Mini-Connector and push
the Silver Inner Drill Sleeve (7163-1156) to bone over the
drill. The length measurements are taken from the calibrations off the drill in relation the Silver Inner Drill Sleeve to
bone (Figure 27). The appropriate length screw is selected
and attached to the Screwdriver. Remove the Drill and Silver
Inner Drill Sleeve. Attach Screwdriver handle to power or
use manual T-handle (7163-1172) and place screws in
bone. It is recommended that final tightening of the screw
should always be under manual control using the T-Handle
(7163-1172) (Figure 28).
Figure 28
11
TROCHANTERIC ANTEGRADE SURGICAL TECHNIQUE FOR STANDARD FEMORAL OR RECON LOCKING MODES
B. Screw Length Gauge — Predrill through both cortices. Insert the Gold Outer Drill Sleeve (7163-1152)
to bone. Insert the Screw Length Gauge through the
Gold Outer Drill Sleeve from the far cortex to measure
for proper screw length (Figure 29). The appropriate
length screw is selected and attached to the
Screwdriver. Attach Screwdriver handle to power or
use manual T-handle (7163-1172) and place screws
in bone (Figure 30). It is recommended that final
tightening of the screw should always be under
manual control using the T-Handle (7163-1172).
C. (Optional) Power Technique — The distal interlocking technique can be performed without a guide
by the freehand method. This can be done by placing
the Ruler (7163-1128) on top of the leg and taking a
C-arm image. Count the number of grooves between
the edge of the Ruler and the far cortex. The grooves
are 5 mm apart. The Ruler should be placed against
the edge of the near cortex for the best measurement.
The screw length should be adjusted 3-5 mm longer
for magnification error correction to ensure that the
far cortex is reached. The proper length screw is
attached to the Screwdriver. After “perfect circles”
are confirmed, insert the screw into bone through
the Gold Outer Drill Sleeve (7163-1152) using power.
The Screwdriver contains a laser-marked ring. This
ring should be stopped short of the Gold Outer Drill
Sleeve to prevent final seating of the screw by power.
It is recommended that final tightening of the screw
should always be under manual control using the
T-Handle (7163-1172) (Figure 31).
D. Targeter — The Targeter (7163-1174) may be used
to assist in placing additional distal screws after the
first screw has been inserted (Figure 32). Be sure
to use the Medium Screwdriver (7163-1166) when
placing the first screw in bone as outlined in the
above options. Leave the Medium Screwdriver
attached to the first screw in the bone. Choose
whether you will be “statically” or “dynamically”
12
Figure 29
Figure 30
Figure 31
Figure 32
TROCHANTERIC ANTEGRADE SURGICAL TECHNIQUE FOR STANDARD FEMORAL OR RECON LOCKING MODES
locking the implant. Place the appropriate labeled
hole on the Targeter over the Screwdriver and push
to skin. Making sure that the Targeter can freely
rotate. The Short Screwdriver (7163-1168) can also
be attached to the side of the Targeter. It acts as a
handle to stabilize the Targeter as well as an aid in
reducing exposure of the hand during imaging. Use
the C-Arm to rotationally locate the second hole.
Once the position is found, place the Short Drill
(7163-1112) through the wire hole on the Targeter
and into bone to maintain position. The MiniConnector (7163-1186) provides a convenient
attachment of the drill to power. Make an incision at
the tip of the barrel for the second screw and insert
the Silver Inner Drill Sleeve and Targeter to bone.
Use of the standard pre-drill technique or power
technique can be used to finish screw placement
(Figure 33). The optional power technique can also
be used for the second screw by removing the Silver
Inner Drill Sleeve (Figure 34).
Figure 33
Figure 34
Figure 35
Figure 36
13 DISTAL SCREWS FOR SHORT TAN (BLUE): For
the short TAN, distal locking is performed by attaching
the 8.5 mm Grey FAN Guide (7163-1119) with the Blue
Tip. The blue tip is designed to provide guided targeting
of the distal screw holes in the Short TAN implants
(Figure 35).
CLOSURE
14 On completion of the procedure, the proximal
guide is removed with the Guide Bolt Wrench
(7163-1140), wounds are irrigated and closed
in a standard fashion (Figures 36, 37 and 38).
Figure 37
Figure 38
13
SURGICAL TECHNIQUE FOR TRIGEN NAIL CAPS WITH TAN
TriGen Nail Caps are available in 5 mm (7163-3005),
10 mm (7163-3010), 15 mm (7163-3015) and 20 mm
(7163-3020) sizes to accommodate most countersinking
needs. The cap length includes the external driving hex.
ASSEMBLY AND PLACEMENT WITH FAN
1. The proper cap is chosen based on the amount of
countersinking measured on preoperative templates or
from the drill guide countersinking measurements.
2. It is recommended that the polyethylene plug be
removed in nail caps being used for Trochanteric
Antegrade Nails. Removing the plug allows for easier
removal using a guided approach if the nail has
to be removed. Use the Obturator (7163-1122)
to press on and expel the polyethylene plug located
inside the nail cap.
3. After removal of the plug, attach the nail cap to the
Long Captured Screwdriver (7163-1164).
4. Insert the nail cap through the incision and tighten it
to the nail. Be sure to properly align the nail cap to the
nail to prevent cross threading. Some resistance may
be felt. This is due to a pennig process to the threads
designed to minimize backout.
5. Reconfirm that the nail cap is properly located all
the way down to the nail.
1. Make a 1 cm to 2 cm incision in approximately the
same location as the original incision used to place
the nail.
2. Locate the nail cap.
3. Place a 3.2 mm Guide Wire (7163-1190) into the
cannulation of the nail cap.
4. Place the 12.5 mm Entry Reamer (7163-1116) down
to the nail cap and use to clear debris.
5. Remove the retaining shaft from the Long Captured
Screwdriver (7163-1164).
6. Attached the T-Handle (7163-1172) to the screwdriver
(7163-1164).
7. Place the screwdriver over the 3.2 mm Guide Wire
(7163-1190) and secure to the external hex of the
nail cap.
8. Remove the guide wire.
9. Remove the T-Handle and replace the retaining shaft
back inside the screwdriver.
11. Remove the nail cap.
NAIL CAPS
14
The TriGen Nail Cap was designed to allow for a percutaneous and captured approach when removing from an
Antegrade Nail as follows:
10. Reattach T-Handle and secure the captured
screwdriver to the nail cap.
6. Disconnect the Captured Screwdriver.
Cat. No.
7163-3005
7163-3010
7163-3015
7163-3020
REMOVAL OF NAIL CAP
Length
5 mm
10 mm
15 mm
20 mm
SURGICAL TECHNIQUE FOR NAIL EXTRACTION
The TriGen Instrument Set offers two extractors for nail
explanation. When removing a TriGen nail, the Large
Extractor (7163-1178) is always used. For nails other
than TriGen, the Large Extractor is designed to remove
diameters greater than 10 mm. The Small Nail Extractor
(7163-1176) is designed for 10 mm diameters or smaller
nails. These two nail extractors are designed to remove
virtually any nail.
STANDARD TECHNIQUE FOR
LARGE OR SMALL EXTRACTOR
Standard Technique for Large or Small Extractor
1. Patient is placed in correct position on a radiolucent
table for imaging.
2. Make a 1 cm to 2 cm incision in approximately the
same location as the original incision used to place
the nail.
3. Place the 3.2 mm Tip Threaded Guide Wire
(7163-1190) into the top of the nail.
4. Insert the 12.5 mm Entry Reamer (7163-1116) to the
top of the nail and use to clear debris and overgrowth.
5. After debris has been cleared, remove the guide wire
and Entry Reamer and assemble the Impactor to the
appropriate extractor.
6. The extractor is placed through the incision down to
the top of the nail and screwed into the nail using
slight, downward pressure. Be sure to check alignment
of the extractor and nail to make assembly easier.
7. After the Extractor is tightened to the nail, the Guide
Bolt Wrench (7163-1140) is placed into the hole
on the Impactor (7163-1185) handle to provide
additional leverage.
OPTIONAL CANNULATED TECHNIQUE
FOR LARGE EXTRACTOR ONLY
MOST USEFUL WHEN REMOVING ANTEGRADE
FEMORAL NAILS
1. Patient is placed lateral decubitus on a radiolucent
table for imaging.
2. Make a 1 cm to 2 cm incision in approximately the
same location as the original incision used to place
the nail.
3. Place the 3.2 mm Tip Threaded Guide Wire
(7163-1190) into the top of the nail.
4. Insert the 12.5 mm Entry Reamer (7163-1116) over
the guide wire to the top of the nail and use to clear
debris and overgrowth.
5. Once the debris is cleared, remove the Entry Reamer,
leaving the 3.2 mm Tip Threaded Guide Wire in
place.
6. Assemble the One-Piece Impactor (7163-1185)
to the Large Extractor.
7. The Large Extractor is placed over the wire and
guided to the top of the nail. The Extractor is screwed
into the nail using slight downward pressure.
8. After the extractor is tightened to the nail, the Guide
Bolt Wrench (7163-1140) is placed into the hole on
the Impactor (7163-1185) handle to provide additional leverage.
9. Remove all locking screws.
10. The Slotted Hammer (7163-1150) is then placed
on the hammer and used to back slap the nail
and 3.2 mm guide wire out of the bone.
8. Remove all locking screws.
9. The Slotted Hammer (7163-1150) is then placed
on the Impactor and used to back slap the nail
out of the bone.
15
16
CATALOG INFORMATION — NAILS
STANDARD FEMORAL OR RECONSTRUCTION MODES
LEFT
RIGHT
(Lime)
Cat. No.
7163-7230
7163-7232
7163-7234
7163-7236
7163-7238
7163-7240
7163-7242
7163-7244
7163-7246
7163-7248
7163-7250
7163-7330
7163-7332
7163-7334
7163-7336
7163-7338
7163-7340
7163-7342
7163-7344
7163-7346
7163-7348
7163-7350
7163-7430
7163-7432
7163-7434
7163-7436
7163-7438
7163-7440
7163-7442
7163-7444
7163-7446
7163-7448
7163-7450
(Rose)
Description
10 mm x 30 cm
10 mm x 32 cm
10 mm x 34 cm
10 mm x 36 cm
10 mm x 38 cm
10 mm x 40 cm
10 mm x 42 cm
10 mm x 44 cm
10 mm x 46 cm
10 mm x 48 cm
10 mm x 50 cm
11.5 mm x 30 cm
11.5 mm x 32 cm
11.5 mm x 34 cm
11.5 mm x 36 cm
11.5 mm x 38 cm
11.5 mm x 40 cm
11.5 mm x 42 cm
11.5 mm x 44 cm
11.5 mm x 46 cm
11.5 mm x 48 cm
11.5 mm x 50 cm
13
13
13
13
13
13
13
13
13
13
13
mm
mm
mm
mm
mm
mm
mm
mm
mm
mm
mm
x
x
x
x
x
x
x
x
x
x
x
30
32
34
36
38
40
42
44
46
48
50
cm
cm
cm
cm
cm
cm
cm
cm
cm
cm
cm
PROXIMAL
Femoral Lock
Cat. No.
7163-8230
7163-8232
7163-8234
7163-8236
7163-8238
7163-8240
7163-8242
7163-8244
7163-8246
7163-8248
7163-8250
7163-8330
7163-8332
7163-8334
7163-8336
7163-8338
7163-8340
7163-8342
7163-8344
7163-8346
7163-8348
7163-8350
7163-8430
7163-8432
7163-8434
7163-8436
7163-8438
7163-8440
7163-8442
7163-8444
7163-8446
7163-8448
7163-8450
Recon Lock
DISTAL
Length
10 mm x 30 cm
10 mm x 32 cm
10 mm x 34 cm
10 mm x 36 cm
10 mm x 38 cm
10 mm x 40 cm
10 mm x 42 cm
10 mm x 44 cm
10 mm x 46 cm
10 mm x 48 cm
10 mm x 50 cm
11.5 mm x 30 cm
11.5 mm x 32 cm
11.5 mm x 34 cm
11.5 mm x 36 cm
11.5 mm x 38 cm
11.5 mm x 40 cm
11.5 mm x 42 cm
11.5 mm x 44 cm
11.5 mm x 46 cm
11.5 mm x 48 cm
11.5 mm x 50 cm
13 mm x 30 cm
13 mm x 32 cm
13 mm x 34 cm
13 mm x 36 cm
13 mm x 38 cm
13 mm x 40 cm
13 mm x 42 cm
13 mm x 44 cm
13 mm x 46 cm
13 mm x 48 cm
13 mm x 50 cm
TROCHANTERIC (SHORT)
5° Bend
(Blue)
Cat. No.
7163-9215
7163-9315
Length
10.0 mm x 15 cm
11.5 mm x 15 cm
17
CATALOG INFORMATION — SCREWS/NAIL CAPS
5.0 MM CAPTURED SCREW
(Gold) For 10 mm, 11.5 mm & 13 mm Implants
Cat. No.
7163-2220
7163-2225
7163-2230
7163-2235
7163-2240
7163-2245
7163-2250
7163-2255
7163-2260
7163-2265
7163-2270
7163-2275
7163-2280
7163-2285
7163-2290
7163-2295
7163-2200
7163-2205
7163-2210
Length
20 mm
25 mm
30 mm
35 mm
40 mm
45 mm
50 mm
55 mm
60 mm
65 mm
70 mm
75 mm
80 mm
85 mm
90 mm
95 mm
100 mm
105 mm
110 mm
NAIL CAPS
Cat. No.
7163-3005
7163-3010
7163-3015
7163-3020
18
Length
5 mm
10 mm
15 mm
20 mm
6.4 MM CAPTURED
RECON SCREW
(Blue)
Cat. No.
7163-2365
7163-2370
7163-2375
7163-2380
7163-2385
7163-2390
7163-2395
7163-2300
7163-2305
7163-2310
7163-2316*
7163-2320
7163-2325
Length
65 mm
70 mm
75 mm
80 mm
85 mm
90 mm
95 mm
100 mm
105 mm
110 mm
115 mm
120 mm
125 mm
CATALOG INFORMATION — INSTRUMENTATION
Gripper
Cat. No. 7163-1100
Long Pilot Drill
Cat. No. 7163-1110
Short Pilot Drill
Cat. No. 7163-1117
Entry Tool
Cat. No. 7163-1114
12.5 mm Entry Reamer
Cat. No. 7163-1116
14 mm Channel Reamer
Cat. No. 7163-1118
Entry Reamer Connector
Cat. No. 7163-1120
Obturator
Cat. No. 7163-1122
Reducer
Cat. No. 7163-1124
3.0 mm X 1000 mm Ball Tip Guide Rod
Cat. No. 7163-1126
Ruler
Cat. No. 7163-1128
Flex Reamer Extender
Cat. No. 7163-1130
Skin Protector
Cat. No. 7163-1132
19
CATALOG INFORMATION — INSTRUMENTATION
Drill Guide
Cat. No. 7163-1134
Guide Bolt
Cat. No. 7163-1136
Quick Bolt
Cat. No. 7163-1138
Guide Bolt Wrench
Cat. No. 7163-1140
Knee Guide
Cat. No. 7163-1142
Hip Guide
Cat. No. 7163-1144
8.5 mm FAN Guide
Cat. No. 7163-1119
One Piece Impactor
Cat. No. 7163-1185
Hammer
Cat. No. 7163-1150
Gold Outer Drill Sleeve
Cat. No. 7163-1152
Silver Inner Drill Sleeve
Cat. No. 7163-1156
Supracondylar Guide
Cat. No. 7163-1158
6.4 mm Drill
Cat. No. 7163-1160
6.4 mm Tap
Cat. No. 7163-1162
20
CATALOG INFORMATION — INSTRUMENTATION
Long Screwdriver
Cat. No. 7163-1164
Medium Screwdriver
Cat. No. 7163-1166
Short Screwdriver
Cat. No. 7163-1168
Screwdriver Replacement Bars
Cat. No.
7163-1165
7163-1167
7163-1169
Description
Large
Medium
Short
Screw Length Gauge
Cat. No. 7163-1170
Direct Measuring Gauge
Cat. No. 7163-1189
T-Handle (Zimmer-Hall)
Cat. No. 7163-1172
Straight Screwdriver Handle
Cat. No. 7163-1163
Targeter
Cat. No. 7163-1174
Small Extractor
Cat. No. 7163-1176
Large Extractor
Cat. No. 7163-1178
Small AO Adapter
Cat. No. 7163-1184
Trinkle Adapter
Cat. No. 7163-1183
21
CATALOG INFORMATION — INSTRUMENTATION
Mini Connector
Cat. No. 7163-1186
Trinkle Mini Connector
Cat. No. 7163-1187
Tip Threaded Guide Wire
Cat. No. 7163-1190
Flex Reamer Shaft
Cat. No. 7163-1192
Screwdriver Release Handle
Cat. No. 7163-1208
Pilot Nose Reamer Heads
Cat. No.
7111-8233
7111-8234
7111-8235
7111-8236
7111-8237
7111-8238
7111-8239
7111-8240
7111-8241
7111-8242
Description
9.5 mm Head
10.0 mm Head
10.5 mm Head
11.0 mm Head
11.5 mm Head
12.0 mm Head
12.5 mm Head
13.0 mm Head
13.5 mm Head
14.0 mm Head
Modular Reamer Box
Cat. No. 7163-1218
22
CATALOG INFORMATION — INSTRUMENTATION/IMPLANT TRAYS
Instrument Case Set
Cat. No. 7163-1200
Consists of: 7112-9400 Large Outer Case; 7112-9402 Lid for Outer
Case; 7163-1199; and 7163-1201
TriGen Instrument Tray 1
Cat. No. 7163-1199
TriGen Instrument Tray 2
Cat. No. 7163-1201
FAN Case – Left
Cat. No. 7163-1202
FAN Case – Right
Cat. No. 7163-1203
Knee Nail Case
Cat. No. 7163-1204
FAN Case – 13 mm Nails
Cat. No. 7163-1206
Screw Caddy
Cat. No. 7163-1180
Large Outer Case 4.8”
Cat. No. 7112-9400
Small Outer Case 2.4”
Not Shown
Cat. No. 7112-9401
Lid for Outer Case
Shown with Case
Cat. No. 7112-9402
23
IMPORTANT MEDICAL INFORMATION
INTRAMEDULLARY NAIL SYSTEM
SPECIAL NOTE
The Intramedullary Nail System consists of interlocking intramedullary nails, and interlocking fusion nails, and pins. Intramedullary nails contain holes proximally and distally
to accept locking screws. Components are available in many styles and sizes and are
manufactured from various types of metals. The component material is provided on the
outside carton label. Use only components made from the same material together. Do
not mix dissimilar metals or components from different manufacturers. Refer to manufacturer literature for specific product information. All implantable devices are designed
for single use only.
Intramedullary Interlocking Nails are provided with a variety of screw placement options
based on surgical approach, antegrade or retrograde, and indications.
Interlocking Fusion Nails indicated for joint arthrodesis have screw holes for locking on
either side of the joint being fused. The locking screws reduce the likelihood of shortening and rotation of the fusion site.
INDICATIONS
The general principles of patient selection and sound surgical judgment apply to the
intramedullary nailing procedure. The size and shape of the long bones present limiting
restrictions on the size and strength of implants.
Indications for interlocking intramedullary nails include simple long bone fractures;
severely co mminuted, spiral, large oblique and segmental fractures; nonunions and
malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; supracondylar
fractures; bone lengthening and shortening. Interlocking intramedullary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of
the long bones being treated.
In addition to the indications for interlocking intramedullary nails, devices that contain
holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability are indicated for the following: subtrochanteric fractures with
lesser trochanteric involvement; ipsilateral femoral shaft/neck fractures; and
intertrochanteric fractures.
2. Surgical technique information is available upon request. The surgeon should be
familiar with the devices, instruments and surgical technique prior to surgery.
3. The use of locking screws is necessary for strength and compatibility. Please refer to
the surgical technique or product catalogue for information on the correct size of
screws for each nail.
4. The patient should be advised that a second more minor procedure for the removal
of implants is usually necessary.
5. While the surgeon must make the final decision regarding implant removal, wherever
possible and practical for the individual patient, fixation devices should be removed
once their service as an aid to healing is accomplished. In the absence of a bursa or
pain, removal of the implant in elderly or debilitated patients is not suggested.
6. Postoperative instructions to patients and appropriate nursing care are critical. Early
weight bearing substantially increases implant loading and increases the risk of loos ening, bending or breaking the device. Early weight bearing should only be considered where there are stable fractures with good bone-to-bone contact. Patients who
are obese and/or noncompliant, as well as patients who could be pre-disposed to
delayed or non-union, must have auxiliary support. The implant may be exchanged
for a larger, stronger nail subsequent to the management of soft tissue injuries.
7. Even after full healing, the patient should be cautioned that refracture is more likely
with the implant in place and soon after its removal, rather than later, when voids in
the bone left by implant removal have been filled in completely.
8. Patients should be cautioned against unassisted activity that requires walking or
lifting.
9. Postoperative care and physical therapy should be structured to prevent loading of
the operative extremity until stability is evident.
10. Additional postoperative precautions should be taken when the fracture line occurs
within 5 cm of the nail’s screw hole, as this situation places greater stress on the nail
at the location of the transverse screw hole.
In addition to the indications for interlocking intramedullary nails, devices that utilize a
retrograde femoral surgical approach are indicated for the following: severely co mminuted supracondylar fractures with or without difficult intra-articular extension; fractures
that require opening the knee joint to stabilize the femoral condylar segment; fractures
above total knee implants.
POSSIBLE ADVERSE EFFECTS
Indications for the Knee Nail include the following: degeneration, deformity, or trauma of
both the tibiotalar and talocalcaneal articulations in the hindfoot; tibiocalcaneal arthrodesis; combined arthrodesis of the ankle and sub-talar joints; avascular necrosis of the
ankle and sub-talar joints; failed total ankle replacement with sub-talar intrusion; failed
ankle arthrodesis with insufficient talar body; rheumatoid arthritis; severe deformity secondary to untreated talipes equinovarus or neuromuscular disease; and severe pilon
fractures with trauma to the sub-talar joint.
3. Infections, both deep and superficial, have been reported.
1. Loosening, bending, cracking or fracture of the implant components.
2. Limb shortening or loss of anatomic position with nonunion or malunion with rotation
or angulation may occur.
4. Irritational injury of soft tissues, including impingement syndrome.
5. Supracondylar fractures from retrograde nailing.
6. Tissue reactions which include macrophage and foreign body reactions adjacent to
implants.
Knee Fusion Nails are intended for intramedullary knee arthrodesis.
7. Although rare, metal sensitivity reactions and/or allergic reactions to foreign materials
have been reported in patients.
CONTRAINDICATIONS
PACKAGING AND LABELING
1. These systems should not be used in crossing open epiphyseal plates.
2. Insufficient quantity or quality of bone, obliterated medullary canal or conditions which
tend to retard healing, also, blood supply limitations, previous infections, etc.
3. Active infection.
4. The presence of a previously inserted fracture fixation device.
5. Preexisting bone deformity.
6. Hypovolemia, hypothermia and coagulopathy.
7. Mental conditions that preclude cooperation with the rehabilitation regimen.
8. The forearm nail should not be used in children who have not reached skeletal
maturity.
WARNINGS
1. This device is not approved for screw attachment or fixation to the posterior elements
(pedicles) of the cervical, thoracic, or lumbar spine.
2. Intramedullary nails are neither intended to carry the full load of the patient acutely,
nor intended to carry a significant portion of the load for extended periods of time.
3. The correct selection of device components is extremely important. The appropriate
type and size should be selected for the patient. Failure to use the largest possible
components or improper positioning may result in loosening, bending, cracking, or
fracture of the device or bone or both.
4. Do not mix dissimilar metals. Use only stainless steel screws with stainless steel
devices, and Ti-6A1-4V screws with Ti-6A1-4V devices.
PRECAUTIONS
1. Use care in handling and storage of implant components. Cutting, sharply bending or
scratching the surface can significantly reduce the strength and fatigue resistance of
the implant system. This, in turn, could induce cracks and/or noninternal stresses that
could lead to fracture of the implants.
3433199 Rev. 0
24
Components should only be accepted if received by the hospital or surgeon with the fac tory packaging and labeling intact.
STERILIZATION/RESTERILIZATION
Most implants are supplied sterile and have been packaged in protective trays. The
method of sterilization is noted on the package label. All radiation sterilized components
have been exposed to a minimum of 25 kiloGrays of gamma radiation. If not specifically
labeled sterile, the implants and instruments are supplied non-sterile and must be sterilized prior to use. Inspect packages for punctures or other damage prior to surgery.
Metal components may be initially sterilized or resterilized, if necessary, by steam autoclaving in appropriate protective wrapping, after removal of all original packaging and
labeling. Protect the devices, particularly mating surfaces, from contact with metal or
other hard objects which could damage the product. The following process parameters
are recommended for these devices:
• Prevacuum Cycle: 4 pulses (Maximum = 26.0 psig (2.8 bars) & Minimum = 10.0 inHg
(339 millibars)) with a minimum dwell time of 4 minutes at 270°F to 275°F (132°C to
135°C), followed by a 1 minute purge and at least 15 minutes of vacuum drying at 10
inHg (339 millibars) minimum.
• Gravity Cycle: 270°F to 275°F (132°C to 135°C) with a minimum dwell time at temperature of 15 minutes, followed by a 1 minute purge and at least 15 minutes of vacuum
drying at 10 inHg (339 millibars) minimum.
Smith & Nephew does not recommend the use of low temperature gravity cycles or flash
sterilization on implants.
INFORMATION
For further information, please contact Customer Service at (800) 238-7538 for calls
within the continental USA and (901) 396-2121 for all international calls.
Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.
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