5

Proximal Humerus

Operative Technique

AxSOS™

Locking Plate System

Introduction

Distal Lateral Femoral Plate

Proximal Lateral Tibial Plate

Distal Anterolateral Tibial Plate

Distal Medial Tibial Plate

The AxSOS™ Locking Plate System is designed to treat periarticular or intra-articular fractures of theProximal Humerus, Distal Femur,Proximal Tibia, and the Distal Tibia.The system design is based on clinicalinput from an international panel ofexperienced surgeons, data fromliterature, and both practical andbiomechanical testing. The anatomicalshape, the fixed screw trajectory,and high surface quality take intoaccount the current demands ofclinical physicians for appropriatefixation, high fatigue strength,and minimal soft tissue damage.

This Operative Technique contains a simple step-by-step procedure for the implantation of the Proximal Humeral Plate.

Proximal Humeral Plate

3

Features & Benefits

System

• The Proximal Humeral Plate isdesigned with divergent fixed-angledscrew trajectories which provideoptimal biomechanical stability.This helps prevent loss of reduction.

Instruments

• Simple technique, easyinstrumentation with minimalcomponents.

Range

• Longer plates cover a wider range of fractures.

Unthreaded Freedom Holes

• Freehand placement of screws.

• Lag Screw possibility.

‘Waisted’ Plate Shape

• Uniform load transfer.Rounded & Tapered Plate End

• Helps reduce soft tissue irritation.

K-Wire/Reduction/Suture Holes

• Primary/temporary plate and fracture fixation.

• Anchor point for soft tissue re-attachment.

Anatomically Contoured

• Little or no bending required.

• Reduced OR time.

Shaft Holes - Standard or Locking

• Bi-directional shaft holes

• Compression, neutral or buttress fixation.

• Accept Standard 3.5/4.0mm SPS screws.

• Accept Locking Insert for axiallystable screws.

Innovative Locking Screw Design

• Screw is guided into plate.

• Reduced potential for cross threadingand cold welding.

Monoaxial Holes (5)

• Allow axially stable screw placement,bringing stability to construct.

Aiming Block

• Facilitates the placement of the Drill Sleeve.

4

Relative Indications & Contraindications

Relative Indication

The indication for use of this internalfixation device includes fractures of theProximal Humerus.

Relative Contraindications

The physician's education, training andprofessional judgement must be reliedupon to choose the most appropriatedevice and treatment. The followingcontraindications may be of a relativeor absolute nature, and must be takeninto account by the attending surgeon:

• Any active or suspected latentinfection or marked localinflammation in or about the affected area.

• Compromised vascularity that wouldinhibit adequate blood supply to thefracture or the operative site.

• Bone stock compromised by disease,infection or prior implantation thatcan not provide adequate supportand/or fixation of the devices.

• Material sensitivity, documented or suspected.

• Obesity. An overweight or obesepatient can produce loads on theimplant that can lead to failure ofthe fixation of the device or to failure of the device itself.

• Patients having inadequate tissuecoverage over the operative site.

• Implant utilisation that wouldinterfere with anatomical structuresor physiological performance.

• Any mental or neuromusculardisorder which would create anunacceptable risk of fixation failure or complications inpostoperative care.

• Other medical or surgical conditionswhich would preclude the potentialbenefit of surgery.

Detailed information is included in the instructions for use being attachedto every implant.

See package insert for a complete list of potential adverse effects andcontraindications. The surgeon mustdiscuss all relevant risks, including thefinite lifetime of the device, with thepatient, when necessary.

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

5

Operative Technique

Patient Positioning: Beach Chair

Surgical Approach: Deltopectoral

Instrument/Screw Set: 4.0mm

Reduction

Anatomical reduction of the fractureshould be performed by directvisualisation with the help ofpercutaneous clamps. Fracturereduction should be confirmed bydirect vision or fluoroscopy.To aid with this reduction and toprovisionally hold fragments together,(humeral head and/or tuberosity) K-Wires may be used as appropriate.

The tubercles must be repositionedback to their anatomical positionseither using K-Wires (tension bandwiring) or screws as necessary.Care must be taken that these do notinterfere with the required plate andscrew positions.

Consideration must also be taken whenpositioning independent Lag Screwsprior to plate placement to ensure thatthey do not interfere with the plannedplate location or Locking Screwtrajectories.

Bending:

In most cases, the pre-contoured platewill fit without the need for furtherbending. However, should additionalbending of the plate be required(generally at the junction from themetaphysis to the shaft) the BendingIrons (REF 702756) should be used.Bending of the plate in the region ofthe metaphyseal locking holes willaffect the ability to correctly seat theLocking Screws into the plate and istherefore not permitted.

Plate contouring in the shaft regionshould be restricted to the areabetween the shaft holes.Plate contouring may affect the abilityto place a Locking Insert into the shaftholes adjacent to the bending point.

General Guidelines

6

Operative Technique

Conventional direct

Measure off K-Wire Measure off drill

Read off calibration

Locking Screw Measurement

There are four options to obtain theproper Locking Screw length asillustrated below.

Measurement Options

Tissue Reattachment

Special undercuts on the reverse side of the plate correlating to the sixproximal K-Wire holes allows simple passing of sutures for tissuereattachment after final plate fixation.

General Guidelines

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Step 1 – Pre-Operative Planning

Use of the X-Ray Template (REF 981090)or Plate Trial (REF 702787) inassociation with fluoroscopy can help to assist in the selection of anappropriately sized implant (Fig. 1).

If the Plate Trial is more than 90mmaway from the bone, e.g. with obesepatients, a magnification factor of10-15% will occur and must becompensated for. Final intraoperativeverification should be made to ensurecorrect implant selection.

If locking screws are chosen for theplate shaft, pre-operative insertion of Locking Inserts is required.

A 4.0mm Locking Insert (REF 370002)is attached to the Locking Insert Inserter(REF 702762) and placed into thechosen holes in the shaft portion of theplate (Fig. 2). Ensure that the LockingInsert is properly placed. The Insertershould then be removed (Fig. 2A).

Do not implant Locking Inserts withthe Drill Sleeve.

It is important to note that if aTemporary Plate Holder is to be usedprimary distal plate fixation, then aLocking Insert must not be placed inthe same hole as the Temporary PlateHolder (See Step 5).

Fig. 2A

Fig. 3

Operative Technique

Fig. 1

Step 2 – Aiming Block/Plate Insertion Handle Assembly

Screw the appropriate Aiming Block(REF 702716/702717) to the plateusing the Screwdriver T15 (REF 702747). If desired, the Handlefor Plate Insertion (REF 702778) cannow be attached to help facilitate platepositioning (Fig. 3).

Fig. 2

Fig. 4 – Lateral View

8

Step 3 – Plate Application

After skin incision and anatomicalreduction is achieved, apply the plate.The plate should be centered againstthe lateral aspect of the greatertuberosity, ensuring that the plate islateral to the biceps attachment.The superior aspect of the plate shouldsit approximately 10mm below thegreater tuberosity (Fig. 4).

This helps to ensure that the mostinferior Locking Screw is placed asinferiorly as possible within thehumeral head, which minimises thechance for subacromial impingement.

Step 4 – Primary Plate Fixation –Proximal

A 3.5mm Cortical or 4.0mmCancellous Screw is placed in theoblong hole in a neutral position.Using a 2.5mm Drill (REF 700355-230mm or 700347-125mm) andDouble Drill Guide (REF 702418),drill a core hole to the appropriate depth.

The length is then measured using the Depth Gauge for Standard Screws(REF 702879), and 2 to 4mm is added.The appropriate screw is then insertedusing a Screwdriver (REF 702841) anda Screw Holding Sleeve (REF 702732).If inserting a cancellous screw, the nearcortex must be pre-tapped using theTap (REF 702805), and the TeardropHandle (REF 702428). If platereadjustment is required, do not fullytighten the screw (Fig. 5).

Then, a 2.0x230mm K-Wire is insertedinto the most distal metaphysealLocking Screw hole using the K-WireSleeve (REF 702702) in conjunctionwith the Drill Sleeve (REF 702707)(Fig. 6).

Keep in mind that the position of theproximal Locking Screw should be5mm shorter than the circumference of the humeral head.

Using fluoroscopy, the position ofthis K-Wire can be checked to ensurethe correct screw and plate position.Should the axial alignment of the platebe unsuitable, the K-Wire should beremoved, the plate readjusted and theabove procedure repeated until boththe K-Wire and plate are in the desiredposition.

Then, make sure the screw in theoblong hole is fully tightened.

Do not remove the Drill Sleeve and K-Wire Sleeve at this point.

Remove the Handle for Insertion bypressing the metal button at the end of the Handle.

Additional K-Wires can be inserted inthe K-Wire holes to further help securethe plate to the bone.

Operative Technique

Fig. 4 – AP View

Fig. 5

Fig. 6

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Step 5 – Primary Plate Fixation –Distal

The distal end of the plate must nowbe secured. This can be achievedthrough one of four methods:

• A K-Wire inserted in the distal shaftK-Wire hole.

• A 3.5mm Cortical Screw using thestandard technique.

• A 4.0mm Locking Screw with aLocking Insert (see Step 7 – Shaft Locking).

• The Temporary Plate Holder (REF 702776).

In addition to providing temporaryfixation, the Temporary Plate Holderpushes the plate to the bone. Also, ithas a self drilling, self tapping tip forquick insertion into cortical bone.

To help prevent thermal necrosisduring the drilling stage, it isrecommended that this device is inserted by hand.

Once the device has been insertedthrough the far cortex, the threadedouter sleeve/collet is turned clockwiseuntil the plate is in contact with thebone (Fig. 7). The core diameter of thisinstrument is 2.4mm to allow a 3.5mmCortical Screw to be subsequentlyinserted in the same plate hole.

Note: A Locking Insert and lockingscrew should not be used in the holewhere the Temporary Plate Holder is used.

Step 6 – Metaphyseal Locking

As Locking Screws cannot act as Lag Screws, should an interfragmentarycompression effect be required,a 4.0mm Standard Cancellous Screwmust first be placed in the unthreadedmetaphyseal plate hole (Fig. 8) prior tothe placement of any Locking Screws.Consideration must also be taken whenpositioning this screw to ensure that itdoes not interfere with the givenLocking Screw trajectories.

The proximal Locking Screws should be 5mm shorter than thecircumference of the humeral head.

Fixation of the metaphyseal portion of the plate can be started using thepreset K-Wire in the distal locking hole as described in Step 4 for themeasurement of the locking screw.

The length of the screw can be taken by using the K-Wire side of the Drill/K-Wire Depth Gauge (REF 702712) (See Locking Screw MeasurementGuidelines on Page 7).

Remove the K-Wire and K-Wire Sleeve leaving the Drill Sleeve in Place(Fig. 9).

Operative Technique

Fig. 7 – AP View

Fig. 7 – Lateral View

Fig. 8 Fig. 9

10

A 3.1mm Drill (REF 702742) is thenused to drill the core hole for theLocking Screw. Using Fluoroscopy,check the correct depth of the drill,and measure the length of the screw.Avoid penetrating the far cortex of thehumeral head.

The Drill Sleeve should now beremoved, and the correct length4.0mm Locking Screw is inserted using the Screwdriver T15 (REF 702753) and Screw HoldingSleeve (REF 702732).

Final tightening of Locking Screwsshould always be performed manuallyusing the Torque Limiting Attachment(REF 702750) together with the SolidScrewdriver T15 (REF 702753) and T-Handle (REF 702427)(Fig. 10).

This helps to prevent over-tighteningof Locking Screws, and also ensuresthat these Screws are tightened to atorque of 4Nm. The device will clickwhen the torque reaches 4Nm.If inserting Locking Screws underpower, make sure to use a low speed to avoid damage to the screw/plateinterface, and perform final tighteningby hand. The remaining proximalLocking Screws are inserted followingthe same technique with or withoutthe use of a K-Wire.

To ensure maximum stability, it isrecommended that all locking holes are filled with a Locking Screw of theappropriate length (Fig. 11).

The Aiming Block and any metaphysealK-Wires should now be removed.

Operative Technique

Fig. 10

Fig. 11 – Superior View Fig. 11 – AP View

Step 7 – Shaft Fixation

The shaft holes of this plate have been designed to accept either 3.5mmStandard Cortical Screws or 4.0mmLocking Screws together with thecorresponding Locking Inserts (Fig. 12).

If a combination of Standard andLocking Screws is used in the shaft,then the Standard Cortical Screwsmust be placed prior to the Locking Screws. Fig.12 – 14º Transverse AngulationFig.12 – 70º Axial AngulationFig.12 – Locked Hole

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Operative Technique

Option 1 – Standard Screws

3.5mm Standard Cortical Screws canbe placed in neutral, compression orbuttress positions (Fig.13) as desiredusing the standard technique.

These screws can also act as lag screws.

Locking Insert Extraction

Should removal of a Locking Insert be required for any reason, then thefollowing procedure should be used.Thread the central portion (A) of theLocking Insert Extractor (REF 702767)

into the Locking Insert that you wishto remove until it is fully seated (Fig.15). Then turn the outer sleeve/collet(B) clockwise until it pulls the LockingInsert out of the plate (Fig. 16).

The Locking Insert must then bediscarded, as it cannot be reused.

Option 2 – Locking Screws

4.0mm Locking Screws can be placedin a shaft hole provided there is a pre-placed locking insert in the hole(See Step 1).

The Drill Sleeve(REF 702707) isthreaded into the Locking Insert toensure initial fixation of the LockingInsert into the plate. This will alsofacilitate subsequent screw placement.A 3.1mm Drill Bit (Ref.702742) is used to drill through both cortices.

Avoid any angulation or excessive forceon the drill, as this could dislodge theLocking Insert. The screw measurementis then taken. Locking Screws shouldinitially be inserted manually to ensureproper alignment.

If the Locking Screw thread does notimmediately engage the plate thread,reverse the screw a few turns and

re-insert the screw once it is properly aligned.

The appropriate sized Locking Screw is then inserted. Using the Solid Screwdriver T15 (REF 702753)together with the Torque LimitingAttachment (REF 702750) and T-Handle, final tightening is performed (Fig. 14).

Fig. 14

Fig. 15

B

A

Buttress

Compression

Neutral

Fig. 16

Fig. 13 – Drill Sleeve HandleFig. 13 – Drill Guides

Maximum stability of the LockingInsert is achieved once the screw headis fully seated and tightened to 4.0Nm.This procedure is repeated for all holeschosen for locked shaft fixation.

All provisional plate fixation devices (K-Wires, Temporary Plate Holder, etc)can now be removed. Last, using theproximal suture holes, re-attach therotator cuff and greater tubercle.

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Ordering Information - Implants

Stainless Steel Plate Shaft LockingREF Length Holes Holes

Left Right mm

436103 436123 86 3 5436105 436125 112 5 5436108 436128 150 8 5

Stainless Steel SystemREF mm

370002 4.0

PROXIMAL HUMERUS Locking Screws Ø4.0mm Standard Screws Ø3.5, 4.0mm

4.0MM LOCKING INSERT

Note: For Sterile Implants, add ‘S’ to REF

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Stainless Steel ScrewREF Length mm

370514 14370516 16370518 18370520 20370522 22370524 24370526 26370528 28370530 30370532 32370534 34370536 36370538 38370540 40370542 42370544 44370546 46370548 48370550 50370555 55370560 60370565 65370570 70370575 75370580 80370585 85370590 90370595 95

Stainless Steel ScrewREF Length mm

345514 14345516 16345518 18345520 20345522 22345524 24345526 26345528 28345530 30345532 32345534 34345536 36345538 38345540 40345545 45345550 50345555 55345560 60345565 65345570 70345575 75345580 80345585 85345590 90345595 95

Stainless Steel ScrewREF Length mm

338614 14338616 16338618 18338620 20338622 22338624 24338626 26338628 28338630 30338632 32338634 34338636 36338638 38338640 40338642 42338644 44338646 46338648 48338650 50338655 55338660 60338665 65338670 70338675 75338680 80338685 85338690 90338695 95

Stainless Steel ScrewREF Length mm

345414 14345416 16345418 18345420 20345422 22345424 24345426 26345428 28345430 30345432 32345434 34345436 36345438 38345440 40345445 45345450 50345455 55345460 60345465 65345470 70345475 75345480 80345485 85345490 90345495 95

4.0MM LOCKING SCREW, SELF TAPPINGT15 DRIVE

3.5MM CORTICAL SCREW, SELF TAPPING2.5MM HEX DRIVE

Ordering Information - Implants

4.0MM CANCELLOUS SCREW, PARTIAL THREAD2.5MM HEX DRIVE

4.0MM CANCELLOUS SCREW, FULL THREAD2.5MM HEX DRIVE

Note: For Sterile Implants, add ‘S’ to REF

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REF Description

4.0mm Locking Instruments

702742 Drill Ø3.1mm x 204mm

702772 Tap Ø4.0mm x 140mm

702747 Screwdriver T15, L200mm

702753 Solid Screwdriver T15, L115mm

702732 Screw Holding Sleeve

702702 K-Wire Sleeve

702707 Drill Sleeve

702884 Direct Depth Gauge for Locking Screws

702750 Torque Limiter T15/4.0mm

702762 Locking Insert Inserter 4.0mm

702427 T-Handle small, AO Fitting

38111090 K-Wire Ø2.0mm x 230mm

702767 Locking Insert Extractor

702778 Handle for Plate Insertion

702712 Drill/K-Wire Measure Gauge

702776 Temporary Plate Holder

702776-1 Spare Shaft for Temporary Plate Holder

702919 Soft Tissue Spreader (Optional)

702961 Trocar (for Soft Tissue Spreader) (Optional)

702782 Soft Tissue Elevator (Optional)

702756 Bending Irons (x2)

Ordering Information - 4.0mm Instruments

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Ordering Information - 4.0mm Instruments

REF Description

4.0mm Locking Instruments

702717 Aiming Block, Proximal Humerus, Left

702716 Aiming Block, Proximal Humerus, Right

702716-2 Spare Set Screw for Humerus Aiming Block

702787 Plate Trial - Proximal Humerus (without attachment to Handle)

SPS Standard Instruments

700347 Drill Bit Ø2.5mm x 125mm, AO700355 Drill Bit Ø2.5mm x 230mm, AO700353 Drill Bit Ø3.5mm x 180mm, AO702804 Tap Ø3.5mm x 180mm, AO702805 Tap Ø4.0mm x 180mm, AO702418 Double Drill Guide Ø2.5/3.5mm702822 Drill Sleeve Handle702825 Drill Sleeve Ø2.5mm Neutral702829 Drill Sleeve Ø2.5mm Compression702831 Drill Sleeve Ø2.5mm Buttress702709 Percutaneous Drill Sleeve Ø2.5mm702957 Percutaneous Drill Sleeve Ø2.5mm Neutral702879 Depth Gauge 0-150mm for Screws Ø3.5/4.0mm, Titanium702849 Screwdriver Hex 2.5mm for Standard Screws L200mm702485 Solid Screwdriver Hex 2.5mm for Standard Screws L115mm702490 Screwdriver Holding Sleeve for Screws Ø3.5/4.0mm702428 Tear Drop Handle, small, AO Fitting900106 Screw Forceps390192 K-wires 2.0mm x 150mm

Other Instruments

702755 Torque Tester with Adapters

981090 X-Ray Template, Proximal Humerus

Cases and Trays

902955 Metal Base - Instruments902929 Lid for Base - Instruments902930 Instrument Tray 1 (Top)902931 Instrument Tray 2 (Middle)902948 Instrument Tray 3 (Bottom)902932 Screw Rack902949 Metal Base - Screw Rack902950 Metal Lid for Base - Screw Rack902947 Metal Base - Implants902933 Implant Tray - Proximal Humerus902937 Lid for Base - Proximal Humerus902958 Locking Insert Storage Box 4.0mm

Stryker Trauma AGBohnackerweg 1CH-2545 SelzachSwitzerland

www.osteosynthesis.stryker.com

The information presented in this brochure is intended to demonstrate a Stryker product. Always refer to the packageinsert, product label and/or user instructions before using any Stryker product. Surgeons must always rely on their ownclinical judgment when deciding which products and techniques to use with their patients. Products may not be availablein all markets. Product availability is subject to the regulatory or medical practices that govern individual markets. Pleasecontact your Stryker representative if you have questions about the availability of Stryker products in your area.

Stryker Corporation or its subsidiary owns the registered trademark: Stryker.Stryker Corporation or its subsidiary owns, uses or has applied for the following trademarks AxSOS.

Literature Number: 982275LOT B0906

US Patents pending

Copyright © 2006 StrykerPrinted in Switzerland