1.5 mm LCP Modular Mini Fragment System TG

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titanium. Synthes. 3. Cortex screws. – Self-tapping tip facilitates insertion. – Self-retaining ..... 36. 1.5 mm LCP Adaption Plates. Stainless Steel Titanium. Holes.

1.5 mm LCP Modular Mini Fragment System. 1.5 mm instrument and implant modules.

Technique Guide

Table of Contents

Introduction

Surgical Technique

Product Information

1.5 mm LCP Modular Mini Fragment System

2

AO Principles

4

Indications

5

Preoperative Planning and Reduction

6

Insert Plate

7

Insert Screws

10

Implant Removal

16

Implants

17

Instruments

20

Set Lists

21

IMPORTANT: This device has not been evaluated for safety and compatibility in the MR environment. This device has not been tested for heating or migration in the MR environment.

Image intensifier control Synthes

1.5 mm LCP Modular Mini Fragment System. 1.5 mm instrument and implant modules.

The 1.5 mm LCP Modular Mini Fragment System consists of 1.5 mm locking compression plate (LCP) instrument and implant module sets.

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Plates – Low profile to minimize soft tissue irritation – Cut-to-length feature minimizes inventory – Coaxial Combi holes allow the use of a locking screw or a cortex screw in the same round conical plate hole

Synthes 1.5 mm LCP Modular Mini Fragment System Technique Guide

– Available with or without short threaded drill guides preassembled to the plate – Combi holes in the LCP plates allow use of a cortex screw in the compression side of the hole or a locking screw in the threaded side of the hole

preassembled plate

Cut-to-length feature minimizes inventory

Coaxial Combi holes allow the use of a locking screw or a cortex screw in the same round conical plate hole

Locking screws – Self-tapping tip facilitates insertion – Self-retaining StarDrive recess allows improved torque transmission and increased resistance to stripping – Threaded head profile used with LCP plates creates a fixed-angle construct, particularly advantageous in osteopenic bone – Low-profile head sits flush with the plate – Available in stainless steel or titanium

Cortex screws – Self-tapping tip facilitates insertion – Self-retaining StarDrive recess allows improved torque transmission and increased resistance to stripping – Used for compression – Low-profile head sits flush with the plate – Available in stainless steel or titanium

Available with or without short threaded drill guides preassembled to the plate

Synthes

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AO Principles

In 1958, the AO formulated four basic principles, which have become the guidelines for internal fixation.1 Those principles, as applied to the 1.5 mm LCP Modular Mini Fragment System, are: Anatomic reduction Fracture reduction and fixation to restore anatomical relationships. Stable fixation Locking screws create a fixed-angle construct, providing angular stability. Preservation of blood supply Tapered end may facilitate submuscular plate insertion. Submuscular plate insertion may help to preserve tissue viability. Limited-contact plate design minimizes disruption of soft tissue and preserves vascular blood flow for bone healing. Early, active mobilization Early mobilization per standard AO technique creates an environment for bone healing, expediting a return to optimal function.

1. M. E. Müller, M. Allgöwer, R. Schneider, and H. Willenegger. Manual of Internal Fixation, 3rd Edition. Berlin: Springer-Verlag. 1991.

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Synthes 1.5 mm LCP Modular Mini Fragment System Technique Guide

Indications

The Synthes 1.5 mm LCP Modular Mini Fragment System consists of plates and screws and is intended for fixation of small bones and small bone fragments; osteotomies, arthrodeses, replantations, and reconstructions of small bones and small bone fragments, particularly in osteopenic bone.

Synthes

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Preoperative Planning and Reduction

Preoperative planning Use the AO preoperative planner template for the 1.5 mm LCP Modular Mini Fragment System. Required sets 01.114.001 / 01.114.002 or 01.114.501 / 01.114.502 105.200 / 145.200 or 01.111.120 / 01.111.140

1.5 mm LCP Modular Mini Fragment Instrument and Implant Set (stainless steel or titanium) 1.5 mm LCP Modular Mini Fragment Instrument and Implant Set, with Drill Guides (stainless steel or titanium) Modular Hand System (stainless steel or titanium) Modular Mini Fragment LCP Instrument and Implant Set (stainless steel or titanium)

1 Reduce fracture Instruments 292.10 / 492.10 or 292.50*

1.0 mm Kirschner Wire, trocar point (stainless steel or titanium)

399.97

Reduction Forceps, with points

1.0 mm Kirschner Wire, trocar points on both ends (stainless steel)

Reduce the fracture under imaging and, if necessary, fix with Kirschner wires or reduction forceps.

* Also available

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Synthes 1.5 mm LCP Modular Mini Fragment System Technique Guide

Insert Plate

2 Trim plate Instrument 391.98*

Plate Cutter, for 1.0 mm – 2.0 mm plates

The plate cutter can be used on a preassembled plate without removal of the short threaded drill guides. Optional instrument 391.962

Bending / Cutting Pliers

If the bending/cutting pliers are used on a plate preassembled with drill guides, the drill guides must first be removed from the plate. Trim the plate to the desired length using the cutters and remove the burrs.

* Also available

Synthes

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Insert Plate

3 Contour plate (optional) Instrument 03.114.003

Threaded Bending Pin, for 1.5 mm LCP Plates

If necessary, use threaded bending pins to contour the plate to fit the patient’s anatomy. The bending pins can be inserted over the short threaded drill guides or threaded into the screw holes. The threaded bending pins should be used to prevent deformation of the threaded holes while bending. Optional instruments 391.962

Bending / Cutting Pliers

391.963

Universal Bending Pliers

The non-preassembled plates can also be bent using the flat-nosed pliers. Note: If possible, bend LCP plates between the Combi holes. Do not deform the Combi holes during bending or overbend the plates as this may adversely affect insertion of locking screws.

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Synthes 1.5 mm LCP Modular Mini Fragment System Technique Guide

4 Position plate Instruments 292.10 / 492.10 or 292.50*

1.0 mm Kirschner Wire, trocar point (stainless steel or titanium)

398.819

Plate Holding Forceps with swivel foot, 150 mm

399.97

Reduction Forceps, with points

1.0 mm Kirschner Wire, trocar points on both ends (stainless steel)

Position the plate over the reduced fracture using forceps and fix provisionally with Kirschner wires or reduction forceps, if necessary. Note: If using a preassembled plate, the short threaded drill guides must be removed from surrounding holes to allow plate holding forceps to sit flush on the plate. The point of pointed reduction forceps can be inserted in the cannulation of the short threaded drill guides to secure the plate to the bone.

* Also available

Synthes

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Insert Screws

5 Determine screw type Depending on the individual case, cortex screws and / or locking screws may be inserted. Determine where locking screws will be used. Locking or cortex screws can be used in any of the screw holes, with the exception of the nonthreaded elongated hole, which only accepts 1.5 mm cortex screws. If a combination of locking and cortex screws is planned, a cortex screw should be inserted first to pull the plate to the bone. If a locking screw is inserted first, ensure that the plate is held securely to the bone, to avoid spinning of the plate as the screw is locked into the plate.

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Synthes 1.5 mm LCP Modular Mini Fragment System Technique Guide

6 Insert screws in plate head Instruments 03.114.009

StarDrive Screwdriver Shaft, with Holding Sleeve, T4, 66 mm

311.01

Handle, with mini quick coupling

319.004

Depth Gauge, for 1.3 mm and 1.5 mm screws

Alternative instrument 03.114.002

Screwdriver Shaft, T4, 42 mm, self-retaining

for use with 1.5 mm locking screws 03.114.007

1.1 mm Drill Bit, mini quick coupling, 75 mm

for use with 1.5 mm cortex screws 03.114.007

1.1 mm Drill Bit, mini quick coupling, 75 mm

310.141

1.5 mm Drill Bit, mini quick coupling, 65 mm

312.14

1.5 mm / 1.1 mm Double Drill Sleeve

A 1.5 mm cortex screw can be inserted in the nonthreaded elongated hole. Adjust the plate as necessary and tighten the screw. Note: The fracture pattern will dictate the optimal screw placement. Insert 1.5 mm cortex or locking screws in the head of the plate. If a cortex screw will be inserted normal to the plate, the short threaded drill guide can be used. If a cortex screw will be angled or inserted using a lag technique, use the double drill sleeve. Use the 1.1 mm drill bit for the threaded hole and the 1.5 mm drill bit for the gliding hole. Determine the screw length using the depth gauge.

Synthes

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Insert Screws

6. Insert screws in plate head continued Notes: If using a preassembled plate, the short threaded drill guide must be removed from the hole before using the double drill sleeve. If measuring through the short threaded drill guide, subtract 5 mm from the reading, to account for the drill guide. Drill for a 1.5 mm locking screw using the short threaded drill guide preassembled in the plate, and the 1.1 mm drill bit. Measure for screw length using the depth gauge. Note: If measuring through the short threaded drill guide, subtract 5 mm from the reading, to account for the drill guide.

Alternative technique Instrument 03.114.001

1.1 mm LCP Threaded Drill Guide

On non-preassembled plates, thread the 1.1 mm threaded drill guide into the hole and drill. Note: Remove the 1.1 mm LCP threaded drill guide before measuring.

Alternative technique 12

Synthes 1.5 mm LCP Modular Mini Fragment System Technique Guide

7 Insert screws in plate shaft Instruments 03.114.009

StarDrive Screwdriver Shaft, with Holding Sleeve, T4, 66 mm

311.01

Handle, with mini quick coupling

319.004

Depth Gauge, for 1.3 mm and 1.5 mm screws

Alternative instrument 03.114.002

Screwdriver Shaft, T4, 42 mm, self-retaining

for use with 1.5 mm locking screws 03.114.007

1.1 mm Drill Bit, mini quick coupling, 75 mm

for use with 1.5 mm cortex screws 03.114.007

1.1 mm Drill Bit, mini quick coupling, 75 mm

310.141

1.5 mm Drill Bit, mini quick coupling, 65 mm

312.14

1.5 mm / 1.1 mm Double Drill Sleeve

A 1.5 mm cortex screw can be inserted in the nonthreaded elongated hole. Adjust the plate as necessary and tighten the screw. Note: The fracture pattern will dictate the optimal screw placement. Insert 1.5 mm cortex or locking screws in the plate shaft. If a cortex screw will be inserted normal to the plate, the short threaded drill guide can be used. If a cortex screw will be angled or inserted using a lag technique, use the double drill sleeve. Use the 1.1 mm drill bit for the threaded hole and the 1.5 mm drill bit for the gliding hole. Determine the screw length using the depth gauge.

Synthes

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Insert Screws

7. Insert screws in plate shaft continued Notes: If using a preassembled plate, the short threaded drill guide must be removed from the hole before using the double drill sleeve. If measuring through the short threaded drill guide, subtract 5 mm from the reading, to account for the drill guide.

Drill for a 1.5 mm locking screw using the short threaded drill guide preassembled in the plate, and the 1.1 mm drill bit. Measure for screw length using the depth gauge. Note: If measuring through the short threaded drill guide, subtract 5 mm from the reading, to account for the drill guide.

Alternative technique Instrument 03.114.001

1.1 mm LCP Threaded Drill Guide

On non-preassembled plates, thread the 1.1 mm threaded drill guide into the hole and drill. Note: Remove the 1.1 mm LCP threaded drill guide before measuring.

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Synthes 1.5 mm LCP Modular Mini Fragment System Technique Guide

8 Remove short threaded drill guides Instruments 03.114.009

StarDrive Screwdriver Shaft, with Holding Sleeve, T4, 66 mm

311.01

Handle, with mini quick coupling

Alternative instrument 03.114.002

Screwdriver Shaft, T4, 42 mm, self-retaining

Be sure to remove all short threaded drill guides when using preassembled plates. The removable tray located in the bottom of the module can serve as a tool to help remove the short drill guides from the screwdriver shaft. It is recommended to count the short threaded drill guides, to ensure they are all removed before closure.

Synthes

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Implant Removal

Implant removal Instruments 03.114.009

StarDrive Screwdriver Shaft, with Holding Sleeve, T4, 66 mm

311.01

Handle, with mini quick coupling

Alternative instrument 03.114.002

Screwdriver Shaft, T4, 42 mm, self-retaining

Loosen all locking screws first, to prevent the plate from rotating during removal of the last locking screw. Remove all screws in a second step. If the screw threads are stripped, a stripped screw extractor can be used. An extraction bolt or hollow reamer can be used to engage shaft threads for removal.

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Synthes 1.5 mm LCP Modular Mini Fragment System Technique Guide

Implants

1.5 mm Cortex Screws, self-tapping, with T4 StarDrive recess – Used to provide compression or neutral fixation – Low-profile head sits flush in the plate holes – StarDrive recess mates with self-retaining screwdriver and provides improved torque transmission – 6 mm to 24 mm lengths 1.5 mm Locking Screws, self-tapping, with T4 StarDrive recess – Threaded, conical head locks securely in Combi holes of the plate, to provide angular stability – Locked screws allow unicortical screw fixation and load transfer to the near cortex – StarDrive recess mates with self-retaining screwdriver and provides improved torque transmission – 6 mm to 24 mm lengths Note: For information on fixation principles using conventional and locked plating techniques, please refer to the Small Fragment Locking Compression Plate (LCP) Technique Guide.

Screws are made of implant-quality 316L stainless steel or titanium alloy (Ti-6AI-7Nb)

Synthes

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Implants

1.5 mm LCP Plates Stainless Steel Titanium 02.114.002 04.114.002 02.114.004 04.114.004

Holes 4 6

Length (mm) 23 36

1.5 mm LCP Adaption Plates Stainless Steel Titanium 02.114.003 04.114.003 02.114.005 04.114.005

Holes 6 12

Length (mm) 29 59

1.5 mm LCP T-Plates Stainless Steel Titanium 02.114.006 04.114.006 02.114.007

04.114.007

Description 3 holes head, 8 holes shaft 4 holes head, 8 holes shaft

1.5 mm LCP Extended H-Plates Stainless Steel Titanium Description 02.114.010 04.114.010 right 02.114.009 04.114.009 left

1.5 mm LCP Y-Plate Stainless Steel Titanium 02.114.013 04.114.013

1.5 mm LCP Condylar Plate Stainless Steel Titanium 02.114.014 04.114.014

Description 3 holes head, 8 holes shaft

Description 6 holes shaft

Plates are made of implant-quality 316L stainless steel or commercially pure (CP) titanium

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Synthes 1.5 mm LCP Modular Mini Fragment System Technique Guide

Plates, assembled with short threaded drill guides 1.5 mm LCP Plates Stainless Steel Titanium Holes Length (mm) 02.114.502 04.114.502 4 23 02.114.504 04.114.504 6 36

1.5 mm LCP Adaption Plates Stainless Steel Titanium 02.114.503 04.114.503 02.114.505 04.114.505

1.5 mm LCP T-Plates Stainless Steel Titanium 02.114.506 04.114.506 02.114.507

04.114.507

Holes 6 12

Length (mm) 29 59

Description 3 holes head, 8 holes shaft 4 holes head, 8 holes shaft

1.5 mm LCP Extended H-Plates Stainless Steel Titanium Description 02.114.509 04.114.509 left 02.114.510 04.114.510 right

1.5 mm LCP Y-Plate Stainless Steel Titanium 02.114.513 04.114.513

1.5 mm LCP Condylar Plate Stainless Steel Titanium 02.114.514 04.114.514

Description 3 holes head, 8 holes shaft

Description 6 holes shaft

Synthes

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Instruments

03.114.001

1.1 mm LCP Threaded Drill Guide, for 1.5 mm LCP Plates

03.114.002

StarDrive Screwdriver Shaft, T4, 42 mm, self-retaining

03.114.003

Threaded Bending Pin, for 1.5 mm LCP plates

03.114.007

1.1 mm Drill Bit, mini quick coupling, 75 mm

03.114.009

StarDrive Screwdriver Shaft, with Holding Sleeve, T4, 66 mm

310.141

1.5 mm Drill Bit, mini quick coupling, 65 mm

310.971

Countersink, for 1.3 mm and 1.5 mm screws

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Synthes 1.5 mm LCP Modular Mini Fragment System Technique Guide

1.5 mm LCP Modular Mini Fragment Instrument and Implant Sets Stainless Steel (01.114.001) and Titanium (01.114.002)

Module 60.114.001 306.667.96 Instruments 03.114.001 03.114.002 03.114.003 03.114.007 03.114.009 310.141 310.971

1.5 mm LCP Module Case Screw Length Marker Kit

1.1 mm LCP Threaded Drill Guide, for 1.5 mm LCP Plates, 2 ea. StarDrive Screwdriver Shaft, T4, 42 mm, self-retaining Threaded Bending Pin, for 1.5 mm LCP plates, 2 ea. 1.1 mm Drill Bit, mini quick coupling, 75 mm, 2 ea. StarDrive Screwdriver Shaft, with Holding Sleeve, T4, 66 mm 1.5 mm Drill Bit, mini quick coupling, 65 mm, 2 ea. Countersink, for 1.3 mm and 1.5 mm screws

Implants 1.5 mm Locking Screws, self-tapping, with T4 StarDrive recess Length Stainless Steel Titanium (mm) Qty. 02.214.006 04.214.006 6 6 02.214.007 04.214.007 7 6 02.214.008 04.214.008 8 6 02.214.009 04.214.009 9 6 02.214.010 04.214.010 10 6 02.214.011 04.214.011 11 6 02.214.012 04.214.012 12 6 02.214.013 04.214.013 13 6 02.214.014 04.214.014 14 6 02.214.015 04.214.015 15 6 02.214.016 04.214.016 16 4 02.214.018 04.214.018 18 4 02.214.020 04.214.020 20 4 02.214.022 04.214.022 22 4 02.214.024 04.214.024 24 4

1.5 mm Cortex Screws, self-tapping, with T4 StarDrive recess Length Stainless Steel Titanium (mm) Qty. 02.214.106 04.214.106 6 6 02.214.107 04.214.107 7 6 02.214.108 04.214.108 8 6 02.214.109 04.214.109 9 6 02.214.110 04.214.110 10 6 02.214.111 04.214.111 11 6 02.214.112 04.214.112 12 6 02.214.113 04.214.113 13 6 02.214.114 04.214.114 14 6 02.214.115 04.214.115 15 6 02.214.116 04.214.116 16 4 02.214.118 04.214.118 18 4 02.214.120 04.214.120 20 4 02.214.122 04.214.122 22 4 02.214.124 04.214.124 24 4

Note: For additional information, please refer to package insert. For detailed cleaning and sterilization instructions, please refer to http://www.synthes.com/sites/NA/MedicalCommunity/Pages/Cleaning_and_Sterilization.aspx or to the below listed inserts which will be included in the shipping container: —Processing Synthes Reusable Medical Devices—Instruments, Instrument Trays and Graphic Cases—DJ1305 —Processing Non-sterile Synthes Implants—DJ1304

Synthes

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1.5 mm LCP Modular Mini Fragment Instrument and Implant Sets Stainless Steel (01.114.001) and Titanium (01.114.002)

Implants continued Without Short Threaded Drill Guides 1.5 mm LCP Plates, 2 ea. Stainless Steel Titanium 02.114.002 04.114.002 02.114.004 04.114.004

Holes 4 6

Length (mm) 23 36

1.5 mm LCP Adaption Plates, 2 ea. Stainless Steel Titanium Holes 02.114.003 04.114.003 6 02.114.005 04.114.005 12

Length (mm) 29 59

1.5 mm LCP T-Plates, 2 ea. Stainless Steel Titanium 02.114.006 04.114.006 02.114.007 04.114.007

Description 3 holes head, 8 holes shaft 4 holes head, 8 holes shaft

1.5 mm LCP Extended H-Plates, 2 ea. Stainless Steel Titanium Description 02.114.009 04.114.009 left 02.114.010 04.114.010 right 1.5 mm LCP Y-Plate, 2 ea. Stainless Steel Titanium 02.114.013 04.114.013

Description 3 holes head, 8 holes shaft

1.5 mm LCP Condylar Plate, 2 ea. Stainless Steel Titanium Description 02.114.014 04.114.014 6 holes shaft

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Synthes 1.5 mm LCP Modular Mini Fragment System Technique Guide

1.5 mm LCP Modular Mini Fragment Instrument and Implant Sets with Drill Guides Stainless Steel (01.114.501) and Titanium (01.114.502)

Module 60.114.001 306.667.96 Instruments 03.114.001 03.114.002 03.114.003 03.114.007 03.114.009 310.141 310.971

1.5 mm LCP Module Case Screw Length Marker Kit

1.1 mm LCP Threaded Drill Guide, for 1.5 mm LCP Plates, 2 ea. StarDrive Screwdriver Shaft, T4, 42 mm, self-retaining Threaded Bending Pin, for 1.5 mm LCP plates, 2 ea. 1.1 mm Drill Bit, mini quick coupling, 75 mm, 2 ea. StarDrive Screwdriver Shaft, with Holding Sleeve, T4, 66 mm 1.5 mm Drill Bit, mini quick coupling, 65 mm, 2 ea. Countersink, for 1.3 mm and 1.5 mm screws

Implants 1.5 mm Locking Screws, self-tapping, with T4 StarDrive recess Length Stainless Steel Titanium (mm) Qty. 02.214.006 04.214.006 6 6 02.214.007 04.214.007 7 6 02.214.008 04.214.008 8 6 02.214.009 04.214.009 9 6 02.214.010 04.214.010 10 6 02.214.011 04.214.011 11 6 02.214.012 04.214.012 12 6 02.214.013 04.214.013 13 6 02.214.014 04.214.014 14 6 02.214.015 04.214.015 15 6 02.214.016 04.214.016 16 4 02.214.018 04.214.018 18 4 02.214.020 04.214.020 20 4 02.214.022 04.214.022 22 4 02.214.024 04.214.024 24 4

1.5 mm Cortex Screws, self-tapping, with T4 StarDrive recess Length Stainless Steel Titanium (mm) Qty. 02.214.106 04.214.106 6 6 02.214.107 04.214.107 7 6 02.214.108 04.214.108 8 6 02.214.109 04.214.109 9 6 02.214.110 04.214.110 10 6 02.214.111 04.214.111 11 6 02.214.112 04.214.112 12 6 02.214.113 04.214.113 13 6 02.214.114 04.214.114 14 6 02.214.115 04.214.115 15 6 02.214.116 04.214.116 16 4 02.214.118 04.214.118 18 4 02.214.120 04.214.120 20 4 02.214.122 04.214.122 22 4 02.214.124 04.214.124 24 4

Synthes

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1.5 mm LCP Modular Mini Fragment Instrument and Implant Sets with Drill Guides Stainless Steel (01.114.501) and Titanium (01.114.502)

Implants continued With Short Threaded Drill Guides 1.5 mm LCP Plates Stainless Steel Titanium 02.114.502 04.114.502 02.114.504 04.114.504

Holes 4 6

Length (mm) 23 36

1.5 mm LCP Adaption Plates Stainless Steel Titanium 02.114.503 04.114.503 02.114.505 04.114.505

Holes 6 12

Length (mm) 29 59

1.5 mm LCP T-Plates Stainless Steel Titanium 02.114.506 04.114.506 02.114.507 04.114.507

Description 3 holes head, 8 holes shaft 4 holes head, 8 holes shaft

1.5 mm LCP Extended H-Plates Stainless Steel Titanium 02.114.509 04.114.509 02.114.510 04.114.510

Description left right

1.5 mm LCP Y-Plate Stainless Steel Titanium 02.114.513 04.114.513

Description 3 holes head, 8 holes shaft

1.5 mm LCP Condylar Plate Stainless Steel Titanium 02.114.514 04.114.514

Description 6 holes shaft

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Synthes 1.5 mm LCP Modular Mini Fragment System Technique Guide

Also Available

Required Set 01.111.120/ 01.111.140 or 105.200/ 145.200 Instruments 03.114.008 03.114.010 391.98 292.50

Modular Mini Fragment LCP Instrument and Implant Set (stainless steel or titanium) Modular Hand System (stainless steel or titanium)

1.1 mm Drill Bit, Stryker J-latch, 85 mm StarDrive Screwdriver Shaft, T4, 66 mm Plate Cutter, for 1.0 mm – 2.0 mm plates 1.0 mm Kirschner Wire, trocar points on both ends

Lid and Tray 60.114.003 Lid for 1.5 mm LCP Module Case 60.114.004 Tray for Small Threaded Drill Guides, for 1.5 mm module

Synthes

Synthes (USA) 1302 Wrights Lane East West Chester, PA 19380 Telephone: (610) 719-5000 To order: (800) 523-0322 Fax: (610) 251-9056 © 2009 Synthes, Inc. or its affiliates. All rights reserved.

Synthes (Canada) Ltd. 2566 Meadowpine Boulevard Mississauga, Ontario L5N 6P9 Telephone: (905) 567-0440 To order: (800) 668-1119 Fax: (905) 567-3185

Combi, LCP and Synthes are trademarks of Synthes, Inc. or its affiliates.

www.synthes.com Printed in U.S.A.

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J9076-D

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