Trigen Meta Retro St 01362 (1)
Trigen Meta Retro St 01362 (1)
Trigen Meta Retro St 01362 (1)
Table of contents
Introduction...................................................................................2
TRIGEN™ META-NAIL™ Retrograde Femoral Nail Specifications......3
Surgical technique.........................................................................4
Establish the incision and entry point.................................................5
Entry portal acquisition........................................................................6
Entry portal........................................................................................... 7
Alternative technique: Entry portal...................................................... 7
Reduce the fracture..............................................................................8
Determine the implant length..............................................................9
Reamed technique..............................................................................10
Nail assembly...................................................................................... 11
Nail insertion.......................................................................................12
Check nail depth.................................................................................12
Lock the screw....................................................................................13
Distal locking.......................................................................................14
Proximal locking..................................................................................15
TRIGEN Nail Cap and Nail Cap Set screw insertion: optional............16
Nail extraction: optional...................................................................... 17
An alternative method for extraction..................................................18
Catalog information..................................................................... 19
Appendix A................................................................................. 23
Blocking screw technique..................................................................23
Establish the entry portal...................................................................23
AP blocking screw insertion..............................................................23
ML blocking screw insertion..............................................................24
Blocking screw insertion with a reducer...........................................25
Final view: AP and ML blocking screw insertion...............................25
Stability blocking screw insertion......................................................25
Final view: Stability blocking screws..................................................26
Appendix B...................................................................................27
TRIGEN STABLE-LOK™ Nut and Washer.............................................. 27
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.
1
Introduction
The following technique is for informational and
educational purposes only. It is not intended to
serve as medical advice. It is the responsibility
of treating physicians to determine and utilize
the appropriate products and techniques,
according to their own clinical judgment, for
each of their patients. For more information on
the TRIGEN™ META-NAIL™ Retrograde Femoral
Nail System, including its indications for
use, contraindications, and product safety
information, please refer to the product’s
label, the Instructions for Use (REF 81068703)
packaged with the product, and, if using the
TRIGEN SURESHOT™ Distal Targeting System, the
TRIGEN SURESHOT Distal Targeting System User
Manual (REF 7118-1540).
2
TRIGEN™ META-NAIL™ Retrograde Femoral
Nail Specifications
Proximal diameter
10, 11.5 and 13mm
(non-driving end)
Alternative modes No
AP bow radius 2m
* Set does not include all sizes; Additional sizes may be special order only.
3
Surgical technique
Patient positioning
1. Position the patient supine on a radiolucent
table. Flex the affected limb approximately
45° over a posterior support to assist with
fracture reduction (Figure 1). Check for
length and rotation by comparison to the
unaffected limb.
2. Rotate the C-Arm to ensure optimal AP
(anteroposterior) and lateral visualization of
the entire femur. The C-Arm should be able
Figure 1
to freely access the femur up to and including
the intertrochanteric area. A distraction
device may also be applied to obtain and/or
maintain traction.
3. Address intra-articular fracture components
with interfragmentary screw fixation prior to
nail insertion. Be sure to place the screws in
the anterior and posterior aspect of the
distal femur and safely out of the nail’s
intended path.
Note: Cannulated screw Guide Pins allow
confirmation of definitive screw placement
prior to fracture fixation and nail insertion.
4. Use a bolster or radiolucent triangle to
maintain limb position. Rotate the C-Arm to
ensure optimal AP and lateral visualization
of the entire femur. A distraction device may
also be applied to obtain and/or maintain
traction (Figure 2).
Figure 2
Caution: If using the TRIGEN™ SURESHOT™
Distal Targeting System, verify that there are
no metal objects in the immediate targeting
area. Metal interference will cause the
SURESHOT System to be inaccurate.
4
Establish the incision and
entry portal
1. Inspect the Entry Portal Tube (7167-4060)
to ensure that it is not damaged, bent or Entry Portal Tube Honeycomb
chipped. Any flaws in the tube can lead
to damage of the surrounding tendons
and tissues.
2. Assemble the Honeycomb (7167-4075), Entry
Portal Handle (7167-4092), and Entry Tube
(Figure 3) by pulling back the black trigger of Entry Portal Handle
the Entry Portal Handle and inserting the Entry Figure 3
Tube into the handle ring.
Turn the tube until it clicks into the
locked position.
Optional: Suction can be applied to the Entry
Portal Handle.
3. Make a 3–4cm midline skin incision, followed
by a medial parapatellar capsular incision
to expose the intercondylar notch (Figure 4).
Gently retract the patellar
tendon laterally.
Figure 4
5
Entry portal acquisition
Locate the entry point within the intercondylar
notch just anterior and lateral to the femoral
attachment of the posterior cruciate ligament
(Figure 5).
1. Attach a 3.2mm Brad Point Guide Pin
(7167-4130 or 7163-1436) to the drill via the
Figure 5
Mini Connector (7163-1186).
2. Insert the Guide Pin into the distal femoral
metaphysis to a depth of 6–8cm (Figure 6).
Note: The entry portal instrumentation serves
as a soft-tissue protector.
3. The Guide Pin should be in line with the
femoral axis in the AP view and anterior to
Blumensaat’s Line in the lateral view (Figure 7).
Note: If suboptimal Guide Pin insertion
occurs, rotate the Honeycomb within the
Entry Portal Tube to the desired location and
insert another 3.2mm Brad Point Guide Pin
Figure 6
(Figure 8).
Note: Do not over-insert the Guide Pin as
this can establish a false trajectory and cause
fracture malalignment.
Blumensaat’s Line
Figure 7
Figure 8
6
Entry portal
1. After Guide Pin placement, remove the
Honeycomb (7167-4075) from the Entry Tube
along with any additionally inserted
Guide Pins.
2. Attach the 12.5mm Entry Reamer (7163-1116)
to a power drill. Advance the reamer over the
Guide Pin and through the Entry Tube to a
depth of 6–8cm (Figure 8).
3. Check the position of the Entry Reamer via Figure 9
radiographic imaging and then remove the
Entry Reamer and Guide Pin.
Alternative technique:
Entry portal
1. With the Entry Tube and Entry Portal Handle
still in the joint space, attach the T-handle
(7167-4076 or 7167-4576) to the Cannulated
Awl (Figure 9). Figure 10
7
Reduce the fracture
1. Open the Gripper (7167-4080).
2. Insert the smooth end of the 3.0mm Ball Tip
Guide Rod (7163-1626) into the front of the
Gripper (Figure 12) and gently close the
Trigger grip
trigger grip.
3. Connect the 8.5mm Reducer and the Reducer
Connector (7167-4077) so that the words “Slot Figure 12
Figure 15
Figure 16
8
Determine the implant length
1. Confirm that the Ruler (7167-4079) opens
easily. If it does not, adjust the thumb wheel
connection at the end to ensure
free movement.
2. After the Reducer has been removed,
reconfirm the guide rod placement within the
proximal femur.
Figure 17
3. Slide the Ruler over the guide rod until its
metal tip contacts the distal femur (Figure 17).
4. Confirm guide rod position in the window
at the opposite end of the Ruler in order to
ensure accurate implant measurement
(Figure 18). Window
9
Reamed technique
1. Use the 9.0mm End Cutting Reamer Head
(7111-8231) and Flexible Reamer Shaft
(7111-8200) to ream the intramedullary canal
sequentially in half-millimeter increments
to a size 1.0–1.5mm larger than the
selected nail size (Figure 19).
3. Insert the Obturator (7167-4078) into the back
of the reamer unit during retraction to ensure
proper Guide Rod placement during reaming.
4. Continue to confirm correct Guide Rod
placement in the proximal femur Figure 19
throughout reaming.
Note: Periodically move the reamer backward
and forward in the canal to clear debris from
the cutting flutes.
10
Nail assembly
1. Use the Guide Bolt (7165-4506) to attach the Guide Bolt
*The 4.0mm Long Pilot Drill (7163-1110) is interchangeable with the 4.0mm AO Long Drill (7163-1121).
11
Nail insertion
1. Detach and remove the Anterior Drop.
2. Attach the Cannulated Impactor-Medium
(7167-5081) to the drill guide (Figure 23).
3. Orient the drill guide assembly in the AP
(anteroposterior) position.
4. Use light blows on the Slotted Hammer
(7167-4082) to tap and advance the nail over
the guide rod to the desired depth.
Note: If excessive force is required to insert Figure 23
the nail, additional reaming of the
intramedullary canal may be required.
5. Verify fracture reduction as the nail crosses
the fracture site. Pay close attention to rotation,
length, alignment, distraction and/or shortening.
6. Check the final nail position in both the AP and
lateral views for correct alignment.
*The 4.0mm Long Pilot Drill (7163-1110) is interchangeable with the 4.0mm AO Long Drill (7163-1121).
13
Distal locking
1. Make a small incision at the site of screw entry.
2. Insert the gold 9.0mm Drill Sleeve (7163-1152),
4.0mm Drill Sleeve (7167-4083), and Screw
Depth Gauge (7163-1189) through the desired
slot on the Anterior Drop (Figure 28) down to
the bone.
3. Drill both cortices with the 4.0mm Long
Pilot Drill*.
4. Measure for screw length using either the
calibrations on the 4.0mm Long Pilot Drill* or
by removing the 4.0mm Drill Sleeve and using
Figure 28
the Screw Depth Gauge.
5. Attach the appropriate-length screw to the end
of the Medium Hexdriver (7163-1066).
6. Use power to insert the screw through the
gold 9.0mm Drill Sleeve until the laser-etched
ring on the Hexdriver reaches the back of the
Drill Sleeve.
7. Attach the T-handle to the Hexdriver.
8. Manually tighten the screw.
If additional fixation is required, the TRIGEN™
STABLE-LOK™ Nut and Washer (Part #7163-2001)
offers increased purchase in low density or
osteoporotic bone. For information about how
to use the STABLE-LOK Nut and Washer, refer
to Appendix B, “TRIGEN STABLE-LOK Nut and
Washer,” at the back of this document.
*The 4.0mm Long Pilot Drill (7163-1110) is interchangeable with the 4.0mm AO Long Drill (7163-1121).
14
Proximal locking
Proximal locking is performed in the AP
plane using a free-hand technique.
1. Confirm fracture reduction and align the
C-Arm over the desired locking hole.
2. Obtain a “perfect circle” image of the
locking hole.
Note: If using the SURESHOT™ Distal Targeting
System, refer to the TRIGEN™ SURESHOT
Distal Targeting System’s User Manual (REF
7118-1540).
3. Use a blunt object to dimple the skin at the Figure 29
approximate location of the locking hole.
4. Make a small stab incision at the site of
screw entry.
5. Insert the 4.0mm Long Pilot Drill* and drill
both cortices.
6. Measure for screw length using the Screw
Depth Gauge.
or
Leave the drill in place, insert the Long Screw
Length Sleeve down to bone, and read the
exposed calibrations from the drill (Figure 29).
7. Use the Medium Hexdriver/T-handle assembly
to insert the appropriate-length screw.
*The 4.0mm Long Pilot Drill (7163-1110) is interchangeable with the 4.0mm AO Long Drill (7163-1121)
15
TRIGEN™ Nail Cap and Nail Cap
Set screw insertion: optional
1. Remove the drill guide/Anterior Drop assembly.
2. Attach the selected Nail Cap (Figure 30) or Figure 30
Nail Cap Set Screw to the Medium Hexdriver/
T-handle assembly.
3. Insert the Nail Cap into the end of the nail
until it is tight.
Note: The TRIGEN Nail Cap Set screw
engages the most distal locking screw to
create a fixed construct.
Figure 31
Note: If cross-threading occurs, rotate the Nail
Cap or Nail Cap Set Screw counter-clockwise
until its threads line up with those of the nail.
Proceed with Nail Cap insertion until it is tight.
16
Nail extraction: optional
Standard technique
1. Use the Medium Hexdriver/T-handle
assembly to remove the Nail Cap or Nail Cap
Set Screw (if implanted), all of the proximal
locking screws, and all but one of the distal
locking screws.
2. Thread the Cannulated Impactor-Medium
(7167-5081) or Cannulated Impactor-Long
(7163-1185)* into the back of the Disposable
Nail Extractor (7163-1320)**.
3. Thread the assembly into the end of the nail. Figure 32
Percutaneous technique
In the absence of a Nail Cap or Nail Cap
Set Screw:
1. Use the Medium Hexdriver/T-handle assembly
to remove all proximal locking screws and all
but one of the distal locking screws.
2. Under fluoroscopy, insert a 3.2mm Brad Point Figure 33
Guide Pin into the end of the nail either using
power or by hand (Figure 33).
3. Make a incision large enough to accept the
12.5mm Entry Reamer at the pin-skin site.
4. Advance the 12.5mm Entry Reamer over the
pin and into the end of the nail to remove any
bony ingrowth (Figure 34).
Note: It is the flared portion of the Entry
Reamer that enters the top of the nail.
5. Thread the Cannulated Impactor-Medium or
Cannulated Impactor-Long (7163-1185) into Figure 34
* The Cannulated Impactor-Long is located in the original TRIGEN™ Instrument Set (7163-1326).
** The Disposable Nail Extractor (7163-1320) is interchangeable with the Large Nail Extractor located in the original TRIGEN
Instrument Set (7163-1326) and the HFN™ Instrument Set (7170-0001).
17
An alternative method
for extraction
Guide rod jamming technique Guide rods
1. Advance the end of a 3.0mm Ball Tip Guide Cat. No. Description
Rod through the end of the nail. 7175-1146 2.0mm x 600mm Ball Tip Guide Rod
2. Insert the smooth end of a 2.0mm ball tip 7163-1626 3.0mm x 1000mm Ball Tip
guide rod (7175-1146) in the same manner.
3. With both guide rods in place, attach the
Additional removal items
Gripper to the end of the 3.0mm Ball Tip
Cat. No. Description
Guide Rod.
115074 Large Extractor Hook*
4. Pull the Gripper back so that it wedges the ball 115073 Small Extractor Hook*
tip against the 2.0mm Guide Rod.
5. Backslap against the Gripper with the Slotted
Hammer to extract the nail.
*Available sterile packed. For nail removal only: do not use for nail insertion.
18
Catalog information
19
TRIGEN™ META-NAIL™ Blocking Screw
Instrument Set Instrument Set (Optional)
Set No. 7165-4002 Set No. 7165-4001
META-NAIL Disposables
Set No. 7165-4003
*The 4.0mm Long Pilot Drill (7163-1110) is interchangeable with 4.0mm AO Long Drill (7163-1121)
**The 4.0mm Short Drill (7163-1117) is interchangeable with 4.0mm AO Short Drill (7163-1123)
***The Disposable Nail Extractor (7163-1320) is interchangeable with the Large Nail Extractor (7163-1278)
located in the original TRIGEN Instrument Set (7163-1326) and the HFN™ Instrument Set (7170-0001)
20
Implants
5.0mm Internal Captured Screws (Gold) TRIGEN™ META-NAIL™ 10mm Retrograde Femoral
Set No. 7165-1000
Cat. Item Length
7164-5020 5.0mm x 20mm Cat. Item Length
5.0mm
7164-5022 5.0mm x 22.5mm 7165-3018 18cm
7164-5025 5.0mm x 25mm 7165-3020 20cm
7164-5027 5.0mm x 27.5mm 7165-3022 22cm
7164-5030 5.0mm x 30mm 7165-3024 24cm
7164-5032 5.0mm x 32.5mm 7165-3026 26cm
7164-5035 5.0mm x 35mm 7165-3028 28cm
7164-5037 5.0mm x 37.5mm 7165-3030* 30cm
7164-5040 5.0mm x 40mm 7165-3032* 32cm
7164-5042 5.0mm x 42.5mm
7165-3034* 34cm
7164-5045 5.0mm x 45mm
7164-5047 5.0mm x 47.5mm
7164-5050 5.0mm x 50mm Cat. Item Length
7164-5052 5.0mm x 52.5mm 7165-3036* 36cm
7164-5055 5.0mm x 55mm 7165-3038* 38cm
7164-5057 5.0mm x 57.5mm 7165-3040* 40cm
7164-5060 5.0mm x 60mm 7165-3042* 42cm
7164-5062 5.0mm x 62.5mm
7165-3044 44cm
7164-5065 5.0mm x 65mm
7165-3046 46cm
7164-5067 5.0mm x 67.5mm
7165-3048 48cm
7164-5070 5.0mm x 70mm
7165-3050 50cm
7164-5072 5.0mm x 72.5mm
7164-5075 5.0mm x 75mm
7164-5077 5.0mm x 77.5mm
7164-5080 5.0mm x 80mm
7164-5085 5.0mm x 85mm
7164-5090 5.0mm x 90mm
7164-5095 5.0mm x 95mm
7164-5100 5.0mm x 100mm
7164-5105 5.0mm x 105mm
7164-5110 5.0mm x 110mm
STABLE-LOK™ Nut
(Used with 5.0mm internal captured screws)
Cat. No. 7163-2001
CAUTION: U.S. Federal law restricts these devices to sale by or on the order of a physician.
* Contained in the standard implant set
22
Appendix A
Blocking screw technique
Incision and entry point
1. Make a 3–4cm midline incision, followed by
a medial parapatellar capsular incision to
expose the intercondylar notch.
2. Gently retract the patellar tendon laterally.
Note: Locate the entry point within the Figure 1
intercondylar notch just anterior and lateral
to the femoral attachment of the posterior
cruciate ligament (Figure 1).
Figure 2
Figure 3
23
3. Adjust the cartridge proximally or distally
within the Blocking Screw Device to determine
blocking screw position.
4. Insert the gold 9.0mm Drill Sleeve and silver
4.0mm Drill Sleeve into the desired cartridge
hole and down to the bone (Figure 4).
5. Drill both cortices with the 4.0 mm Long
Pilot Drill*.
Note: Use caution during drilling and insertion Figure 4
of blocking screws in the AP plane. Do not
drill past the posterior cortex or insert a screw
that is too long. Damage to the neurovascular
structures located posterior and distal femur
may result.
6. Read the exposed drill bit calibrations to
determine the screw length or remove the
4.0mm Drill Sleeve and measure with the
Screw Depth Gauge.
7. Use the Medium Hexdriver/T-handle assembly
to insert the screw until the screw engages the Figure 5
far cortex.
8. Implant the distal blocking screw and reduce
the fracture.
9. Pass the 11.0mm T-handle Awl into the
proximal fragment (Figure 5).
10. Reposition either the Blocking Screw Cartridge
or the awl as necessary and repeat this
blocking screw technique for additional nails.
* The 4.0mm Long Pilot Drill (7163-1110) is interchangeable with the 4.0mm AO Long Drill (7163-1121).
24
Blocking screw insertion with
a reducer
Blocking screws can also be inserted by
attaching the Blocking Screw Device to the
Reducer instead of the 11.0mm T-handle Awl
(Figure 8). Follow the previously described
blocking screw insertion technique.
25
Final view: Stability
blocking screws
1. Once stability blocking screw insertion is
complete, remove the Blocking Screw
Attachment and Anterior Drop from the
drill guide.
2. Obtain both AP and lateral radiographic
images to confirm accurate placement
(Figures 12 and 13).
Figure 12
Figure 13
26
Appendix B
TRIGEN™ STABLE-LOK™ Nut
and Washer
The TRIGEN STABLE-LOK Nut and Washer
(7163-2001) offers increased purchase in low
density or osteoporotic bone. Used with a
corresponding 5.0mm TRIGEN Internal Hex
Figure 1
Head Screw (Figure 1), the STABLE-LOK Nut
and Washer resists screw back-out while
improving fixation.
To implant the cortical screw, use the
TRIGEN 4.0mm Long Pilot Drill (7163-1121),
the TRIGEN Screw Depth Gauge (7163-1189)
and a second TRIGEN T-Handle (7167-4076
or 7167-4576). Alternatively, use the optional
Straight Ratcheting Driver (7175-1141) attached
to a short or medium TRIGEN Hexdriver
(7163-1068; 7163-1066).
1. Use powered instrumentation to advance the
TRIGEN 4.0mm Long Pilot Drill into the bone.
2. Continue to advance the drill until full
penetration of the opposite cortex and soft
tissue is complete.
3. Make a small incision over the drill bit and
down to the cortex to allow a path for the
STABLE-LOK Nut.
Note: Ensure sufficient soft tissue release to
properly seat the nut.
4. Remove the retaining rod from the
Multipurpose Driver (7163-1161).
5. Assemble the STABLE-LOK Nut (Figure 2) onto
the driver, guide it over the Long Pilot Drill,
Figure 2. STABLE-LOK Nut
and thread the nut securely into the bone.
6. Remove the drill.
7. Insert the TRIGEN Screw Depth Gauge
(7163-1189) into the 4.0mm hole and
hook it onto the far side of the nut.
Note: The length of the Internal Hex Head
Screw should correspond exactly with the
reading on the Screw Depth Gauge.
Note: If a lag technique will be used, consider
the appropriate amount of compression when
choosing the correct screw length.
27
8. Attach the Multipurpose Driver (Part #7163-1161)
to a second T-handle or Straight Ratcheting
Driver (7175-1141).
9. Insert the Multipurpose Driver through the
STABLE-LOK™ incision portal to hold the nut in
place while inserting the screw.
10. Place the Washer on the Internal Hex Head
Screw, and advance the screw through the
pre-drilled hole until it engages the
STABLE-LOK Nut on the far cortex (Figure 3).
Figure 3
28
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USA
Telephone: 1-901-396-2121
Information: 1-800-821-5700
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