AxSOSLocking Plate System

Han

d &

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stHand & Wrist

Operative Technique• Volar Distal Radius

2 3

Contents

Page

1. Introduction 4

2. Features & Benefits 5

3. Indications, Precautions & Contraindications 6

Indications 6

Precautions 6

Contraindications 6

4. Operative Technique 7

General Guidelines 7

Step 1 – Surgical Approach 8

Step 2 – Fracture Reduction 8

Step 3 – Plate Bending 9

Step 4 (Optional) – Locking Inserts 9

Step 5 – Initial Fixation 10

Step 6 – Plate Positioning 11

Step 7 – Metaphyseal Screw Fixation 11

Step 8 – Shaft Fixation 13

5. Additional Tips 14

Ordering Information – Implants 15

Ordering Information – 3.0mm Instruments 17

Ordering Information – Instruments 18

This publication sets forth detailed recommended procedures for using Stryker Osteosynthesis devices and instruments.

It offers guidance that you should heed, but, as with any such technical guide, each surgeon must consider the particular needs of each patient and make appropriate adjustments when and as required.

A workshop training is recommended prior to first surgery.

All non-sterile devices must be cleaned and sterilized before use. Follow the instructions provided in our reprocessing guide (L24002000). Multi-component instruments must be disassembled for cleaning. Please refer to the corresponding assembly/disassembly instructions.

See package insert (V15011 and V15013 ) for a complete list of potential adverse effects, contraindications, warnings and precautions. The surgeon must discuss all relevant risks, including the finite lifetime of the device, with the patient, when necessary.

Warning: Fixation Screws:Stryker Osteosynthesis bone screws are not approved or intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

4 5

Features & Benefits

System

• The Distal Volar Radius Plate is designed with divergent fixed-angled screw trajectories

The AxSOS Extremity Plating System is Stryker’s range of axially stable locking plates with locking screws designed to treat intra-articular fractures.

The system includes 3mm Distal Radius Plates, 4mm Proximal Humeral Plates, 4mm Compression Plates, 4mm Reconstruction Plates and 3mm One-Third Tubular Plates (locking and non-locking), as well as a complete range of Locking, Cortical and Cancellous Screws.

This Operative Technique contains a simple step-by-step procedure for the implantation of the Distal Volar Radius Plate.

3mm Distal Radius Plate

4mm Proximal Humeral Plate

3mm Locking Insert

4mm Locking Insert

4mm Recon Plate

1/3 Tubular Plate

1/3 Tubular Standard Plate4mm Compression Plate

Rounded & Tapered Plate End

• Designed to help facilitate sliding of plates sub-muscularly

Waisted plate shape

• Uniform load transfer

Aiming Blocks

• Facilitate the placement of the Drill Sleeve

• Provides attachment point for Plate Insertion Handle.

Innovative Locking Screw design

• Screw is guided into plate

• May reduce potential for cross threading or cold-welding

K-Wire/Reduction holes

• Primary/temporary plate and fracture fixation

Shaft Holes - Standard or Locking

• Accepts standard 2.7mm and 3.5mm SPS screws

• Accept Locking Insert for axially stable screws

Anatomically contoured

• Little or no bending required

• Facilitates for better soft tissue coverage

Unthreaded Freedom Holes

• Freehand placement of screws

• Lag screw possibility

Monoaxial holes

• Allow axially stable screw placement for bringing stability to the construct

Introduction

Instruments

• Simple technique, with easy to use instrumentation

• Compatible with MIPO (Minimally Invasive Plate Osteosyn-thesis) technique using state of the art instrumentation

Range

• Longer plates cover a wider range of fractures

6 7

Indications, Precautions & Contraindications

Indications

Contraindications

PrecautionsThe indication for use of this internal fixation device includes metaphyseal extra and intra-articular fractures of the Distal Radius.

The physician’s education, training and professional judgment must be relied upon to choose the most appropriate device and treatment. Conditions presenting an increased risk of failure include:

• Any active or suspected latent infection or marked local inflammation in or about the affected area.

• Compromised vascularity that would inhibit adequate blood supply to the fracture or the operative site.

• Bone stock compromised by disease, infection or prior implantation that cannot provide adequate support and/or fixation of the devices.

• Material sensitivity, documented or suspected.

• Obesity. An overweight or obese patient can produce loads on the implant that can lead to failure of the fixation of the device or to failure of the device itself.

• Patients having inadequate tissue coverage over the operative site.

• Implant utilization that would interfere with anatomical tructures or physiological performance.

• Any mental or neuromuscular disorder which would create an unacceptable risk of fixation failure or complications in post-operative care.

• Other medical or surgical conditions which would preclude the potential benefit of surgery.

Stryker Osteosynthesis systems have not been evaluated for safety and compat-ibility in MR environment and have not been tested for heating or migration in the MR environment, unless specified otherwise in the product labeling or respective operative technique.

General GuidelinesPatient Positioning:

Surgical Approach:

Instrument / Screw Set:

Supine

Longitudinal incision along the flexor carpi radialis tendon

3mm

Operative Technique

Reduction Anatomical reduction of the fractureshould be performed either bydirect visualization with the help of reduction clamps and/or K-Wires. A bridging external fixator is only exceptionally used in distal radius fractures. Fracture reduction of the articular surface and should be confirmed by direct vision, or fluoroscopy. Use K-Wires as necessary to temporarily secure the reduction.

Typically, K-Wires set parallel to the joint axis will not only act to hold and support the reduction, but also may help to visualize/identify the joint. Care must be taken that these do not interfere with the required plate and screw positions.

Consideration must also be taken when positioning independent Lag Screws prior to plate placement to ensure that they do not interfere with the planned plate location or Locking Screw trajectories.

If any large bony defects are present they should be filled by either bone graft or bone substitute material.

Note: When using a sub muscular technique, please refer to the relevant section on page 18.

BendingIn most cases, the pre-contoured plate will fit without the need for further bending. However, should additional bending of the plate be required (generally at the junction from the metaphysis to the shaft) the Bending Irons (REF 702756) should be used. Bending of the plate in the region of the metaphyseal locking holes will affect the ability to correctly seat the Locking Screws into the plate and is therefore not permitted.

Plate contouring in the shaft region below the oblong hole is not recommended. Plate contouring will affect the ability to place a Locking Insert into the shaft holes adjacent to the bending point.

Caution: Bone Screws are not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

See package insert for warnings, precautions, adverse effects and other essential product information.

Detailed information is included in the instructions for use attached to each implant.

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Operative Technique

Step 1 – Surgical ApproachThe customary approach used would be a longitudinal incision along the flexor carpi radialis tendon (Fig 2).

After fracture exposure, direct or indirect fracture reduction should be obtained and verified fluoroscopically. Temporary K-Wire fixation and/or reduction forceps can aid in maintaining reduction, provisionally holding fragments together.

Step 2 – Fracture Reduction

Fig. 2

Operative Technique

In most cases the pre-contoured plate will fit without the need for further bending. However, should additional bending of the shaft be required (generally at the metaphyseal/diaphyseal junction to the shaft) the bending irons (REF 702901) should be used (Fig. 3).

Note: Alternative Bending Irons (REF 702756) are available as alternative instruments to the extremity plating system.

Bending of the plate in the region of the metaphyseal locking holes will affect the ability to correctly seat the locking screws into the plate and is therefore not recommended. Plate contouring in the shaft region should be restricted to the area between the compression holes.

Note: Damage made to the compression holes will affect the placement of the locking inserts.

Step 3 – Plate Bending

Fig. 3Bending Irons in plate

Step 4 (Optional) – Locking Inserts Pre-operative insertion of LockingInserts is highly recommended.

In the case that the (optional) locking mode is preferred in the shaft portion of the plate, preoperative insertion of Locking Inserts is highly recommended. A 3.0mm Locking Insert (REF 370001) should be attached to the Locking Insert-Inserter (REF 702761) and inserted into the required hole in the shaft portion of the plate (Fig. 4 and 5). The Inserter should then be removed and the Drill Sleeve threaded into the Locking Insert.

Note: Do not place Locking Inserts with the Drill Sleeve.

Fig. 5Fig. 4

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Operative Technique

The Distal Radius Aiming Block (Left, REF 702727, Right, REF 702726) is applied to the plate with the Aiming Block Screw. It should be tightened with the torque limiting screwdriver (REF 702759)(Fig. 6).

Primary plate fixation can be achieved by inserting a 2.7mm or 3.5mm Cortical Screw into the Oblong Adaptation Hole in the shaft portion of the plate.

The Double Drill Guide (702416) can be used with the 2.0mm Drill Bit (REF 700346) for a 2.7mm Cortical Screw in the Oblong Adaptation Hole. Alter-natively, the Double Drill Guide (REF 702418) can be used with a 2.5mm Drill Bit (REF 700347) for a 3.5mm Cortical Screw. (Fig. 7). The cortical screw length can be measured off the Depth Gauge (REF 702875) (Fig. 8). When inserting the screw, do not fully tighten until final positioning is achieved (Fig. 9).

Oblong Adaption Hole

Fig. 7

Fig. 8 Fig. 9

Fig. 6

Operative Technique

Final plate positioning is determined under fluoroscopic control by adjusting the plate proximally or distally (Fig. 10 and 11).

Note:Final position is dependent on anatomy and fracture pattern.

To ensure positioning, use the optional K-Wire Sleeve (REF 702701) in conjunction with the Drill Sleeve (REF 702706).

Step 6 – Plate Positioning

Should interfragmentary compression be required, a 2.7/3.5mm Standard Screw must first be placed in the unthreaded metaphyseal plate hole (i.e. Freedom Hole) prior to the placement of any Locking Screws. As this is a variable angle hole, consideration must be taken when positioning this screw so that it does not interfere with the fixed angle trajectories of the Locking Screws.

While leaving the initial radial K-Wire construct (from Step 6) in place, the remaining metaphyseal Locking Screws can now be inserted. The order of screw holes is dependent on fracture pattern and surgeon preference. Prior to inserting a Locking Screw, a 2.3mm Drill (REF 702741) is used to drill the core hole for the Locking Screws (Fig. 13).

Step 7 – Metaphyseal Screw Fixation

Note: The K-Wire Sleeve (REF 702701) is not a standard instrument in The Extremity Plating System.

A 1.6x150mm K-Wire should be inserted into the most radial locking screw hole, aiming into the styloid process (Fig. 12).

Using fluoroscopy, the position of the K-Wire can be checked until the optimal placement in the styloid process is achieved.

Note: In some bones, mainly smaller individuals, it may be necessary to use K-Wires in both the styloid hole as well as the most ulnar hole to ensure that the radio-ulnar joint is not violated.

Fig. 10 Fig. 11 Fig. 12

Fig. 13

12 13

Operative Technique

Locking Screw Measurement Options

Length of Locking Screws can be measured utilizing the direct Depth Gauge (REF 702883) (Fig. 14) or via the 2.3mm Drill Bit (Fig. 15).

Note: The threaded Drill Sleeve (REF 702706) MUST be used to maintain drill alignment and facilitate the subsequent locking of the screws into the plate. The instrument helps to ensure that the screw heads are fully seated so as to help avoid possible soft tissue irritation.

The Drill Sleeve can now be removed and the correct length 3.0mm Locking Screw inserted using the T8 Torque Limiting (REF 702759) Screwdriver and Screw Holding Sleeve (REF 702731) (Fig. 16).

If the Locking Screw thread does not immediately engage the plate thread, reverse the screw a few turns and re-insert the screw once it is properly aligned.

Care must be taken to avoid penetration of the opposite cortex because this may result in extensor tendon damage. Metaphyseal screw trajectory can be seen below (Fig. 17).

Fig. 14Conventional direct

Fig. 15Measure of drill

Fig. 17Fig. 16

Note: • The Torque Limiters require

routine maintenance. Refer to the Instructions for Proper Maintenance of Torque Limiters (REF. V15020).

• Ensure the screwdriver tip is fully seated in the screw head, but do not apply force during tightening.

Operative Technique

Step 8 – Shaft Fixation

Final Plate and Screw Positions (Fig. 21–23)

The shaft holes of this plate have been designed to accept either 2.7/3.5mm Standard Cortical Screws or 3.0mm Locking Screws. Locking Screws can be inserted in the predrilled locking holes or together with the corresponding Locking Inserts (Fig. 18).

Note: • If a combination of Standard and

Locking Screws is used in the shaft, the plate fixation should begin with Standard Cortical Screws prior to the Locking Screws. Always lag before you lock (Fig. 19 and Fig. 20)

• Screw Heads of 3.5mm cortical screws are prominent in the shaft holes

• The predrilled locking holes are not intended for the insertion of Standard Cortical Screws

Fig. 21 Fig. 22 Fig. 23

Fig. 18 Fig. 19 Fig. 20

Locked Hole

(Non-locked holes only)

49° Axial Angulation 5° Transverse Angulation

14 15

Additional Tips

1. Always use the threaded Drill Sleeve when drilling for Locking Screws (threaded plate hole or Locking Insert).

2. Always insert locking screws manu-ally using the Torque Limiting Screwdriver. Avoid any angulations or excessive force on the screwdriver, as this could cross-thread the screw. Note: Do not insert screw at an angle.

It is recommended to start insert-ing the screw using “the three finger technique” on the torque limiting screwdriver.

4. It is advisable to tap hard (dense) cortical bone before inserting a Locking Screw.

Free hand drilling may lead to a misalignment of the Screw and therefore may result in screw jamming during insertion. It is essential to drill the core hole in the correct trajectory to facilitate accurate insertion of the Locking Screws.

If the Locking Screw thread does not immediately engage the plate thread, reverse the screw a few turns and re-insert the screw once it is properly aligned.

The spherical tip of the Tap precisely aligns the instrument in the pre-drilled core hole during thread cutting. This facilitates subsequent screw placement.

3. If power insertion is selected after manual start (see above), use low speed only, do not apply axial pressure, and never push the screw through the plate. Allow the single, continuous threaded screw design to engage the plate and cut the thread in the bone on its own, as designed. Stop power insertion approximately 1cm before engaging the screw head in the plate.

Power can negatively affect Screw insertion, if used improperly, damaging the screw/plate interface (screw jamming). This can lead to screw heads breaking or being stripped.Again, if the Locking Screw does not advance, reverse the screw a few turns,and realign it before you start re-insertion.

5. Do not use power for final insertion of Locking Screws. It is imperative to engage the screw head into the plate using the Torque Limiting Attach-ment. Ensure that the screwdriver tip is fully seated in the screw head, but do not apply axial force during final tightening. If the screw stops short of final position, back up a few turns and advance the screw again (with torque limiter on).

Ordering Information – Implants

3.0MM DISTAL VOLAR RADIUS PLATE

3.0MM LOCKINg INSTERT

Stainless Steel Description Shaft Locking Length REF Holes Holes in mm Left Right

436003 436023 Distal Volar Radius Plate 3 Holes 4 Holes 60 436004 436024 Distal Volar Radius Plate 4 Holes 4 Holes 71 436006 436026 Distal Volar Radius Plate 6 Holes 4 Holes 93 436008 436028 Distal Volar Radius Plate 8 Holes 4 Holes 115 436010 436030 Distal Volar Radius Plate 10 Holes 4 Holes 136

Stainless Steel System REF mm

370001 3.0

Note: • All implants and instruments are

included in the Extremity Plating System.

• Implants can be ordered sterile packed. Add "S" following refer-ence number.

16 17

Ordering Information – Implants Technique Ordering Information – 3.0mm Instruments

3.0MM LOCKINg SCREWSELF-TAPPINg, T8 DRIVE

4.0MM CANCELLOUS SCREWFULL THREAD, 2.5MM HEx DRIVE

2.7MM CORTICAL SCREWSELF-TAPPINg, 2.5MM HEx DRIVE

4.0MM CANCELLOUS SCREWPARTIAL THREAD, 2.5MM HEx DRIVE

3.5MM CORTICAL SCREWSELF-TAPPINg, 2.5MM HEx DRIVE

Stainless Steel Length REF mm

Stainless Steel Length REF mm

Stainless Steel Length REF mm

Stainless Steel Length REF mm

Stainless Steel Length REF mm

371008371010371012371014371016371018371020371022371024371026371028371030

345410345412345414345416345418345420345422345424345426345428345430345432345434345436345438345440345445345450345455345460

349608349610349612349614349616349618349620349622349624349626349628349630

345510345512345514345516345518345520345522345524345526345528345530345532345534345536345538345540345545345550345555345560

338610338612338614338616338618338620338622338624338626338628338630338632338634338636338638338640338642338644338646338648338650338655338660

81012141618202224262830

1012141618202224262830323436384045505560

81012141618202224262830

1012141618202224262830323436384045505560

1012141618202224262830323436384042444648505560

Note: • All implants and instruments are

included in the Extremity Plating System.

• Implants can be ordered sterile packed. Add "S" following refer-ence number.

REF Description

3.0mm Locking Instruments

702727 Distal Radius Aiming Block, Left

702726 Distal Radius Aiming Block, Right

702741 Drill Ø2.3mm × 125mm

702771 Tap Ø3.0mm × 130mm

702731 Screw Holding Sleeve

702706 Drill Sleeve

702883 Direct Depth Gauge for Locking Screws

702761 Locking Insert Inserter

702759 Torque Limiter Screwdriver T8/3.0mm

REF Description

SPS Standard Instruments

700346 Drill Bit 2.0mm × 125mm, AO 700347 Drill Bit 2.5mm × 125mm, AO 700348 Drill Bit 2.7mm × 125mm, AO 700349 Drill Bit 3.5mm × 125mm, AO 702801 Tap 2.7mm × 125mm, AO 702802 Tap 3.5mm × 125mm, AO 702803 Tap 4.0mm × 125mm, AO 702811 Countersink for 2.7/3.5/4.0mm Screws 702427 T-Handle Small, AO Fitting 702428 Teardrop-Handle Small, AO Fitting 702416 Double Drill Guide 2.0/2.7mm 702418 Double Drill Guide 2.5/3.5mm 702821 Parallel Drill Guide 702875 Depth Gauge 0-70mm for Screws 2.7/3.5/4.0mm 702841 Screwdriver Hex 2.5mm for Standard Screws L200mm 702485 Solid Screwdriver Hex 2.5mm for Standard Screws L115mm 702490 Screwdriver Holding Sleeve for Screws 3.5/4.0mm 702489 Screwdriver Holding Sleeve for 2.7mm Screws 900106 Screw Forceps 390157 K-Wires 1.25mm × 150mm 390164 K-Wires 1.6mm × 150mm 390192 K-Wires 2.0mm × 150mm 702459 Threaded Guide Wire (1.4mm × 150mm) 710302 Bending Templates (Recon 8 Holes) 710303 Bending Templates (Recon 18 Holes) 710305 Bending Templates (Compression 8 Holes) 710306 Bending Templates (Compression 18 Holes)

Note: All implants and instruments are included in the Extremity Plating System.

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Ordering Information – Instruments Notes

Note: All implants and instruments are included in the Extremity Plating System.

REF Description

Reduction Instruments 700151 Hook 700153 Ball Spike 702901 Bending Irons - Small Fragment 702931 Repositioning Forceps - L175 702926 Repositioning Forceps - L130 702932 Repositioning Forceps 700664 Hohmann Retractor 6mm 700665 Hohmann Retractor 8mm 700666 Periosteal and Freer Elevator

Optional Instruments 702756 Bending Irons - AxSOS Distal Radius 702701 K-Wire Sleeve - AxSOS Distal Radius

Cases and Trays 902885 Metal Base - Instruments 902886 Lid for Base - Instruments 902887 Instrument Tray 1 (Top) 902888 Instrument Tray 2 (Middle) 902889 Instrument Tray 3 (Bottom) 902890 Screw Rack with Lid 902891 Silicon Mat 902893 Lid for Screw Rack

Manufactured by:

Stryker Trauma AGBohnackerweg 1CH - 2545 SelzachSwitzerland

www.osteosynthesis.stryker.com

Distributed by:

Stryker 325 Corporate DriveMahwah, NJ 07430t: 201 831 5000

www.stryker.com

This document is intended solely for the use of healthcare professionals. A surgeon must always rely on his or her own professional clinical judgment when deciding whether to use a particular product when treating a particular patient. Stryker does not dispense medical advice and recommends that surgeons be trained in the use of any particular pro-duct before using it in surgery.

The information presented is intended to demonstrate a Stryker product. A surgeon must always refer to the package insert, product label and/or instructions for use, including the instructions for Cleaning and Sterilization (if appli-cable), before using any Stryker product. Products may not be available in all markets because product availability is subject to the regulatory and/or medical practices in individual markets. Please contact your Stryker representative if you have questions about the availability of Stryker products in your area.

Stryker Corporation or its divisions or other corporate affiliated entities own, use or have applied for the following trademarks or service marks: AxSOS, Stryker. All other trademarks are trademarks of their respective owners or holders.

The products listed above are CE marked.

Literature Number : LTADV-OT Rev 1

Copyright © 2013 Stryker

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