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Cleaning and Sterilization Guides

Cleaning, Sterilization, Inspection for Osteosynthesis Medical Devices L24002000

Instructions

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Instructions for Cleaning, Sterilization, Inspection and Maintenance of Osteosynthesis Medical Devices

Contents 1. Introduction Warnings and Precautions 2. Processing Instructions 3. Cleaning Inspection Packaging 4. Sterilization 5. Storage before Use 6. References 7. Manufacturers of Stryker Osteosynthesis Medical Devices

Page 3 3 4 5 8 8 9 11 11 11

Appendix 1 Cleaning agents and disinfectants used during validation of the processing instructions

Appendix 2 Generic product groups defined for the cleaning validation

13 13

Appendix 3 Guidelines to check proper functionality of the medical devices

16 16

1. Introduction

This document is intended to give general guidance on how medical devices supplied by one of the Stryker Osteosynthesis manufacturing locations (see manufacturer addresses in section 7) may be processed to prepare them for use. It also gives instructions for inspection to determine when an instrument has reached the end of its serviceable life and must be replaced. This document is provided in conjunction with the assembly and disassembly instructions for multi-component instruments which must be disassembled prior to cleaning and the instructions for use which come with the products. Stryker Osteosynthesis has demonstrated the processes described in these instructions to be capable of being effective.

Equipment, operators, cleaning agents and procedures all have a contribution to the efficacy of the processing and the healthcare facility should ensure that the combination actually in use results in a medical device which is safe for use. Alternative methods of processing may be equally suitable. In the event of conflicting national cleaning and sterilization requirements, these shall prevail over Stryker Osteosynthesis' recommendations. This applies particularly to the different procedures for inactivation of prions.

Warnings and Precautions •

•

Devices labeled “for single use must not be reprocessed only” for re-use. When single use devices are supplied non-sterile and require sterilization before use, the appropriate sections of these instructions may be applied unless other specific instructions are provided in the package insert. Single use devices must not be reused, as they are not designed to perform as intended after the first usage. Changes in mechanical, physical or chemical characteristics introduced under conditions of repeated use, cleaning and re-sterilization may compromise the integrity of the design and/or material leading to diminished safety, performance and/or compliance with relevant specifications. Please refer to the device label to identify single or multiple use and/or cleaning and re-sterilization release. Stryker Osteosynthesis medical devices are not normally used in surgical procedures where they contact low or high risk TSE

(Transmissible Spongiform Encephalophaties) infective tissue as defined by World Health Organization (WHO), Robert Koch Institute (RKI) etc.. Therefore decontamination procedures with highly aggressive agents [i.e. sodium hydroxide (NaOH), sodium hypochloride (NaOCl)] are not necessary and, for normal processing, are not recommended because material degradation may occur. The sterilization parameters recommended in this document are not intended and not suitable for inactivation of prions.

2. Processing Instructions The sequence of steps required to prepare medical devices for re-use or to prepare new devices for initial use are summarized in the chart below. More detailed instructions for each step are given on the following pages.

Point of Use

  

Remove gross soil Rinse in running water Place in aldehyde-free disinfectant bath

Transport to Processing Area

 

Avoid mechanical damage Minimize time before cleaning

Preparation for Cleaning



Disassemble where possible

    

Remove gross soil Soak in cleaning solution Brush, operate moving parts Rinse in running water Inspect, place on absorbent paper

Pre-Cleaning

Manual

Manual Cleaning and Disinfection

      

Automatic (recommended)

Soak in ultrasonic bath Clean with brushes or cleaning wires Rinse with syringe/running water Soak in disinfectant solution Clean with brushes Rinse with syringe/running water Dry (compressed air/wipes/oven)

Automated Cleaning and Disinfection in Washer-Disinfector

   

Load into washer-disinfector Connect cannulations to rinsing ports, arrange products Operate washer-disinfector cycle Inspect, dry

Inspection

 

Visual inspection Functional check

Packaging

 

Store devices in dedicated trays or wire baskets Single or double packaging

Sterilization



Steam autoclave

Storage

 

Control environment Control shelf life

3. Cleaning Two methods of cleaning Stryker Osteosynthesis medical devices are provided in these instructions, a manual method and a method using an automated washer disinfector. Whenever possible the automated method should be used. The automated cleaning process is more reproducible and therefore more reliable, and staff are less exposed to the contaminated devices and the cleaning agents used. Whichever method is used, staff should use suitable protective clothing and equipment at all times. In particular take note of the instructions provided by the cleaning agent manufacturer for correct handling and use of the product. The guidance concentrations and times for device immersion in the cleaning solutions and/or disinfectants given by the detergent manufacturers shall be observed. If these concentrations and times are exceeded significantly,

discoloration or corrosion could occur with some materials. This could also happen if rinsing after cleaning and/or disinfecting is insufficient. For cleaning or disinfecting medical devices only specifically formulated cleaning agents and/or disinfectants (detergents) should be used. As not all cleaning agents and disinfectants may be available around the globe, criteria for the selection of appropriate detergents are provided in Appendix 1. A list of cleaning agents and disinfectants which Stryker Osteosynthesis used in the validation of these processing instructions is also provided in Appendix 1. Stryker Osteosynthesis does not recommend any specific cleaning and/or disinfection agent. A general description of suitable agents is included in Appendix 1.

Preparation for cleaning

Directly after application (within a maximum of 2 hours postoperatively) remove gross soil using absorbent paper wipes. Additionally, intensive rinsing of the medical devices with fluent water or transfer of the medical devices into a bath with an aldehydefree disinfectant solution meeting the criteria given in Appendix 1 is highly recommended.

Disassemble the device where possible. See instructions provided in the operative technique or separate information available from your Stryker representative.

Avoid mechanical damage, e.g. do not mix heavy devices with delicate ones. Pay particular attention to cutting edges, both to avoid injury and damage to the medical device. Get the medical devices to the point where cleaning is to be performed as soon as practical. If transfer to the processing area is likely to be delayed, consider covering the medical devices with a damp cloth or store the medical devices in closed boxes to avoid drying of soil.

Caution: Stryker Osteosynthesis trays are intended for sterilization, transport and storage of medical devices. They are not designed for cleaning and disinfection in the fully equipped state. The devices must be removed from the tray for adequate cleaning results.

The quality of the water used for diluting cleaning agents and/or

Point of use

Transport to processing area

disinfectants and for rinsing medical devices should be carefully considered. Application of freshly prepared purified water/highly purified water or sterile water for rinsing purposes (according to the pharmacopeias) with less than 10 cfu/ml and 0.25 EU/ml is highly recommended. Mineral residues from hard water as well as higher contamination with microorganisms and endotoxins can result in staining of the device or prevent effective cleaning and decontamination.

•

Pre-Cleaning

• Remark: The pre-cleaning step can be ommitted in case of direct subsequent manual cleaning and disinfection. In case of highly contaminated medical devices to be subjected to an automatic cleaning process, pre-cleaning in an ultrasonic bath is recommended. Equipment required: • Cleaning bath or vessel large enough to allow complete immersion of the instruments. • Freshly prepared cleaning solution using a cleaning agent intended for manual cleaning which meets the 5

• •

criteria given in Appendix 1, with concentration, temperature, and soaking time not less than specified in the detergent manufacturer´s instructions (but temperature not exceeding 50 °C) Brushes – soft and firm, bottle brushes or cleaning wires for cannulations etc. Personal protective equipment as recommended by the cleaning agent supplier (minimum overalls, gloves, face/eye shield) Absorbent paper Syringes (volumes 1 to 50 ml depending on the size of the cannulations to be rinsed)

Caution: Never use metal brushes or steel wool for (pre-) cleaning.

3. Cleaning

Procedure • Remove gross soil using paper wipes and solution of cleaning agent. • Immerse medical device in solution of cleaning agent. • Ensure that all surfaces are thoroughly wetted, using a syringe to ensure that solution reaches all parts of cannulations etc. Ensure that air is not trapped within features of the device when immersing in the solution. • Soak at minimum for the time recommended by the detergent manufacturer´s instructions.

•

Using suitable brushes (only soft brushes, never metal brushes or steel wool) or cleaning wires clean the medical device thoroughly paying particular attention to rough surfaces and features where soil may be shielded from the brushing. Use a firm bristle brush for cleaning bone-cutting features such as drill tips, reamer flutes and the teeth of broaches. Use a bottle brush of appropriate diameter for cannulations. Ensure that the brush passes the whole length of each cannulation at least three times.

• •

•

Operate articulating devices and those with moving parts. Rinse in running water for at least 1 min until all traces of cleaning solution are removed. Pay particular attention to cannulations and blind holes as well as hinges and joints between mating parts. At least three times complete rinsing by application of a syringe (volume 1-50 ml) is required. Visually inspect for any remaining soil and repeat the steps above if necessary. Allow to drain on absorbent paper or transfer immediately to cleaning step.

Manual cleaning and disinfection

Caution: Combined cleaning and disinfection procedures are only recommended in case of medical devices which are contaminated to an extremely little extent.

•

Cleaning

or cleaning wires (for small channels) to reach all parts of the device. Syringes (volumes 1 to 50 ml depending on the size of the channels to be rinsed) Freshly prepared purified water/ highly purified water or sterile water for rinsing purposes. •

Equipment required: • Ultrasonic bath large enough to allow complete immersion of the medical device. Frequency 25 – 50 kHz, temperature according to detergent manufacturer`s instructions. • Cleaning agent intended for manual cleaning and suitable for ultrasonic treatment which meets the criteria given in Appendix 1; concentration as specified in detergent manufacturer’s instructions. • Suitable brushes (only soft brushes, never metal brushes or steel wool)

Procedure: • Prepare an ultrasonic bath with a cleaning solution at the concentration and temperature specified in the detergent manufacturer´s instructions. • Immerse the device completely and activate the bath for at least the time specified in the detergent manufacturer´s instructions. • Using suitable brushes (only soft brushes, never metal brushes or steel wool) or cleaning wires (for small channels) clean the device

•

paying particular attention to rough surfaces and features that may be shielded from the brushing action. Additionally, pay particular attention to cannulations and blind holes as well as hinges and joints between mating parts. Rinse cannulations at least three times with a syringe. Rinse for at least 1 min in running water of the specified quality until all traces of cleaning solution are removed. Pay particular attention to cannulations and blind holes as well as hinges and joints between mating parts. Rinse cannulations at least three times with a syringe (volume 1-50ml). If, after completion of the cleaning step in the ultrasonic bath, encrusted soil remained on the device which had to be removed with the brush, the cleaning step must be repeated as described above.

3. Cleaning Disinfection

Equipment required: • Bath large enough to allow complete immersion of the medical device, temperature according to detergent manufacturer`s instructions. • Disinfectant intended for manual disinfection and compatible with the applied cleaning detergent which meets the criteria given in Appendix 1; concentration according to the detergent manufacturer’s instructions. • Syringes (volumes 1 to 50 ml depending on the size of the channels to be rinsed). • Freshly prepared purified water/ highly purified water or sterile water for rinsing purposes. • Filtered medical compressed air (if available) or clean and lint-free single use wipes.

Procedure: • Prepare a bath with a disinfectant solution at the concentration and temperature specified in the detergent manufacturer´s instructions. • Immerse the device completely for at least the time specified in the detergent manufacturer´s instructions. • Rinse cannulations at least three times with a syringe. • Rinse for at least 1 min in running water of the specified quality until all traces of disinfectant solution are removed. Pay particular attention to cannulations and blind holes as well as hinges and joints between mating parts. Rinse at least five times with a syringe (volume 1-50ml).

•

Dry the medical device using medical compressed air and clean and lint-free single use wipes (if required supplemented by postdrying at a clean place for up to 2 hours) or by heating in an oven below 110°C. Visually inspect and repeat complete manual cleaning and disinfection if necessary.

Automated cleaning and disinfection using washer-disinfector (recommended)

Equipment required: • Washer-disinfector with fundamentally approved efficiency (e.g. CE mark or FDA approval according to ISO 15883), properly installed, qualified and regularly subjected to maintenance and testing • Approved thermal disinfection program (A0 value > 3000 or – in case of older devices – application of at least 5 min at 90 °C; chemical disinfection program not recommended due to danger of remnants of the disinfectant on the instruments) with sufficient rinsing steps and filtered air for an active drying program (application of rinsing aids not recommended, danger of remnants) • Final rinsing/disinfection only with freshly prepared purified water/ highly purified water • Cleaning agent intended for

automated cleaning which meets the criteria given in Appendix 1, concentration as specified in the detergent manufacturer’s instructions. Procedure: • Load the medical devices into the washer-disinfector. • Connect cannulations to the rinsing ports of the washer-disinfector. If no direct connection is possible, locate the cannulations directly on injector jets or in injector sleeves of the injector basket. • Avoid contact between devices (movement during washing could cause damage, and washing action could be obstructed). • Arrange medical devices so that cannulations are not horizontal and blind holes incline downwards (to assist drainage).

• • •

Articulating devices should be in the open position. Operate the washer-disinfector cycle. On completion unload the washerdisinfector. Visually inspect each device for remaining soil and dryness. If soil remains repeat the cleaning process including the precleaning stage. Remaining wetness may be removed with medical grade compressed air, clean and lintfree single use wipes (if required supplemented by post-drying at a clean place for up to 2 hours) or by heating in an oven below 110°C.

3. Cleaning Inspection Before preparing for sterilization, all medical devices should be inspected. Generally un-magnified visual inspection under good light conditions is sufficient. All parts of the devices should be checked for visible soil and/ or corrosion. Particular attention should be paid to: • Soil “traps” such as mating surfaces, hinges, shafts of flexible reamers. • Recessed features (holes, cannulations). • Features where soil may be pressed into contact with the device, e.g. drill flutes adjacent to the cutting tip, sides of teeth on broaches and rasps. • Cutting edges should be checked for sharpness and damage. • For devices that may be impacted check that the device is not damaged to the extent that it malfunctions or that burrs have been produced that could damage tissues or surgical gloves. *

Functional checks should be performed where possible: • Mating devices should be checked for proper assembly. • Medical devices with moving parts should be operated to check correct operation (medical grade lubricating oil suitable for steam sterilization can be applied as required). • Rotating instruments (e.g. multiple use drill bits, reamers) should be checked for straightness (this can be achieved by simply rolling the instrument on a flat surface). • “Flexible” instruments, e.g. IM reamers, should be checked for damage to the spiral element.*

Note: Stryker Osteosynthesis usually does not define the maximum number of uses appropriate for re-usable medical devices. The useful life of these devices depends on many factors including the method and duration of each use, and the handling between uses. Careful inspection and functional test of the device before use is the best method of determining the end of serviceable life for the medical device. However, for certain instruments end of life has been defined, verified and specified with either a number of uses or an expiration date. See Appendix 3 for further details.

Packaging Where appropriate the cleaned, disinfected, and checked medical devices should be assembled into the dedicated trays provided. Stryker Osteosynthesis cases/trays should be double wrapped according to AAMI/CSR technique. The packaging for terminally sterilized medical devices should fulfill the following requirements: • EN ISO 11607 • Suitable for steam sterilization (temperature resistance up to at least 141 °C, sufficient steam permeability) • Sufficient protection of the instruments as well as of the sterilization packagings to mechanical damage

* See Appendix 3 for further inspection instructions.

4. Sterilization

Caution: Medical Devices containing thermolabile materials must not be exposed to additional loads in the autoclave!

USA*

Method Cycle Temperature

Steam sterilization (moist heat) is recommended. An autoclave cycle has been validated by Stryker as being capable of achieving sterile medical devices; however autoclave design and performance can affect the efficacy of the process. Healthcare facilities should validate the process that they use, employing the actual equipment and operators that routinely process the devices.

Moist heat sterilization Pre-Vacuum (Pre-Vac) 270°F (132°C)

Exposure Time1 4 minutes Pressure

2-15 PSIA

Drying Time²

30 minutes (minimum, in chamber)

Cool Time

60 minutes (minimum, at room temperature)

Outside USA* Sterilization process

Steam autoclave (moist heat) sterilization using a pre-vacuum (forced air removal) cycle is recommended. Autoclaves should comply with the requirements of, and be validated, maintenanced and checked in accordance with EN 285/EN 13060, EN ISO 17665, and ANSI AAMI ST79. Stryker has validated an autoclave cycle for sterilization of complete medical device cases/trays. Instruments shall be sterilized in the mounting condition as stored on the tray, i.e. if the brackets or recessions in the tray are designed to accomodate multi-component instruments in their assembled state, there is no need to disassemble these instruments for sterilization. The process parameters shown on the right are validated and recommended by Stryker Osteosynthesis for sterilization:

Method Cycle

Moist heat sterilization according to EN ISO 17665 Saturated steam with fractional forced air removal

Exposure Time1

4 minutes Exposure time can be extended to 18 minutes to comply with the recommendation from World Health Organization (WHO), Robert Koch Institute (RKI) etc. Stryker Osteosynthesis medical devices are able to sustain such sterilization cycles.

Temperature

132-137°C (270-277°F)

Drying Time²

recommended: 30 minutes (minimum, in chamber)

1 E xposure time:

Period for which the load and entire chamber is maintained at the sterilization temperature ² D rying time: Period during which steam is removed from the chamber and the chamber pressure is reduced to permit the evaporation of condensate from the load either by prolonged evacuation or by the injection and extraction of hot air or other gases. The drying time varies due to load configuration, wrapping method and material. It is the hospital´s responsibility to validate the appropriate drying time with the sterilization equipment used.

4. Sterilization

Please note that according EN ISO 17665 the final responsibility for validation of sterilization techniques and equipment lies directly with the hospital. To ensure optimal processing all cycles and methods should be validated for different sterilization chambers, wrapping methods and/or various load configurations.

* Caution: These parameters are not applicable to the entire Stryker Osteosynthesis portfolio. There are exceptions for which other validated sterilization cycles are applicable. These are described in the instructions for use and have binding character. If a product is supplied without a package insert and if you are in doubt about the applicable sterilization parameters for a particular product, please contact the manufacturer. Manufacturer addresses are provided in section 7.

Alternative (e.g. UK, NL)*

Method

Moist heat sterilization according to EN ISO 17665

Cycle

Saturated steam with fractional forced air removal

Exposure Time1 3 minutes Exposure time can be extended to 18 minutes to comply with the recommendation from World Health Organization (WHO), Robert Koch Institute (RKI) etc. Stryker Osteosynthesis medical devices are able to sustain such sterilization cycles Temperature

134°C-138°C (273°F-280°F)

Drying Time²

recommended: 30 minutes (minimum, in chamber)

1 E xposure time:

5. Storage before Use

After sterilization, please store the medical devices in the sterilization packagings in a dry and dust-free place. The shelf live is depending on the sterile barrier employed, storage manner, environmental and handling conditions. A maximum shelf life for sterilized medical devices before use should be defined by each health care facility.

6. References (partly relevant for some countries only) 1.

EN ISO 11607 (ANSI AAMI ISO 11607): Packaging for technically sterilized medical devices (replaced EN 868-1 and ISO 11607)

EN ISO 17665 (ANSI AAMI ISO 17665): Sterilization of health care products, moist heat (replaced EN 554 and ISO 11134)

World Health Organization (WHO) and Robert Koch Institute (RKI) recommendations regarding exposure time: WHO/CDS/CSR/APH/2000.3, Annex III, section 2, 6. RKI Communication in "Bundesgesundheitsblatt", April 2002, 45:376-394, table 11

Stryker steam sterilization validation study; Summary report, H. Davis, September 2001 Stryker Trauma GmbH validation report VAL P0011, VAL P0014

10. Stryker Orthopaedics Technical Report T-878 11. Stryker Osteosynthesis Ti2078-09

ANSI/AAMI ST79: Comprehensive guide to steam sterilization and sterility assurance in health care facilities EN ISO 17664 (ANSI AAMI ST81): Sterilization of medical devices Information to be provided by the manufacturer for the processing of resterilizable medical devices

Verbund für angewandte Hygiene e.V. (VAH) DesinfektionsmittelListe, (VAH List of Disinfectants, replaced the DGHM List of Disinfectants) Internal validation reports, not for public use

12. Stryker Osteosynthesis Ti2381-09

Stryker cleaning / decontamination validation study; Summary report, H. Davis, November 2001

7. M anufacturers of Stryker Osteosynthesis Medical Devices Stryker Trauma GmbH Prof.-Küntscher-Str. 1 - 5 D-24232 Schönkirchen Germany phone: +49-4348-702 0 fax: +49-4348-702 172

Stryker Trauma AG Bohnackerweg 1 CH-2545 Selzach Switzerland phone: +41-32-641 6666 fax: +41-32-641 6660

Stryker Leibinger GmbH & Co KG Boetzinger Str. 41 D-79111 Freiburg Germany phone: +49-761-4512 0 fax: +49-761-4512 120

Appendix 1 Cleaning agents and disinfectants used during validation of the processing instructions For cleaning and/or disinfection of medical devices manufactured from aluminium alloys a pH neutral agent should be used*. Contact with strong alkaline detergents or solutions containing iodine or chlorine should be avoided, since the aluminium can be chemically attacked and the instrument may be damaged. For automatic (washer-disinfector) cleaning mild alkaline agents (up to pH 10.9) should be preferred, however use only agents recommended for use in these machines.

In all cases • follow the indications, instructions and warnings provided by the supplier of the cleaning agent and/ or disinfectant, • select only detergents intended for cleaning and/or disinfection of medical devices made of metals and plastics, and • select only disinfectants with approved efficiency (VAH/DGHM or FDA approval or CE mark).

Ensure that the substances listed below are not ingredients of the cleaning or disinfection detergent chosen: • organic, mineral, and oxidizing acids (minimum admitted pH-value 5.5) • strong lyes (maximum admitted pH-value 10.9*) • organic solvents (for example: acetone, ether, alcohol, benzine) • oxidizing agents (for example: peroxides, hypochloride) • halogens (chlorine, jodine, bromine) • aromated, halogenated hydrocarbons.

Notes: • The cleaning agents listed below were used by Stryker Osteosynthesis when validating the instructions for processing provided in this document. • Stryker Osteosynthesis does not recommend these products in preference to others that are available. Other products may perform equally or better in conjunction with the equipment being used. • The instructions provided by the supplier of the detergents should be followed.

• Personal protection for operators should be provided in accordance with the suppliers instructions and safety data sheets Suitability of alternative agents should be checked by reference to the supplier’s information and/or physical testing.

•

Agents for pre-cleaning and manual cleaning (used for validation)

Supplier

Designation

Comment

Johnson and Johnson Cidezyme/Enzol

Suitable for aluminium instruments

Agents for manual disinfection (used for validation)

Supplier

Designation

Comment

Johnson and Johnson

Cidex OPA

Suitable for aluminium instruments

Agents for automatic cleaning/disinfection in a washer disinfector (used for validation)

Supplier

Designation

Comment

Dr. Weigert

Neodisher Mediclean forte

Not recommended for aluminium medical devices*

* In case of aluminium instruments neutral/enzymatic detergents are recommended (for example Neodisher Medizym)

Appendix 2 Generic product groups defined for the cleaning validation For cleaning and sterilization validations, Stryker Osteosynthesis usually applies a "worst case" approach, i.e. the most challenging products are selected as representative test samples. For the cleaning validation we defined the following generic product groups: Group I

One piece instruments

Group I – One piece instrument

Article number Description

Report

1806-2035

PHN Target Device

TI2078/09

62-51217

Drill Guide

TI2078/09

1806-0170w

Hammer

TI2078/09

12-30180

Bi-polar Forceps, Bayonet

TI2078/09

PPSU Templates

TI1737/07

VariAx Trials

Ti2347/09 and Ti2346/09

Group II

Instruments for bone cutting, piercing or scraping Group III

Cannulated instruments

Group II – Instruments for bone cutting, piercing or scraping

Article number Description

Report

Group IV

702807

Tap dia 6.5 × 180mm

TI2078/09

Multi-component instruments

08-01020

Nasal Rasp, fine / very fine

TI2078/09

1806-3026

Stepdrill

TI2078/09

Flexible instruments

0226-4200

Bixcut IM Reamer Head with Dovetail, dia 20

TI2078/09

Group VI

45-20001

Cannulated Screwdriver 2.0mm, AO coupling

TI1448/07

45-20006

Cannulated Tap 2.0mm, AO coupling

TI1448/07

Group V

Storage trays Group VII

Implants With these product groups Stryker Osteosynthesis is covering the division's entire portfolio and the processing instructions can be presented in a generic form. Specific instructions for each product would not give the health care professional or sterilization facility any additional benefit. The representative products listed below were used in the validation.

Group III – Cannulated Instruments

Article number Description

Report

12-04239

Suction Tube, extra long

TI2078/09

01-19510

Mandibular Channel Retractor, Bremerich

TI2078/09

1806-3065

5mm, Spreading Screwdriver

TI2078/09

1320-0190

Gamma3 Stepdrill

TI2078/09

45-20001

Cannulated Screwdriver 2.0mm, AO coupling

TI1448/07

45-20006

Cannulated Tap 2.0mm, AO coupling

TI1448/07

Appendix 2

Group IV – Multi-component instruments

Article number Description

Report

4920-1-010

Hoffmann II Rod to Rod Coupling

TI2078/09

4960-3-000

Hoffmann II Micro Lengthener Assembly

TI2078/09

702428

Elastosil Handle, small

TI2078/09, BML 08037

703566

AxSOS Tibia Targeting Arm

TI2078/09

4936-9-010

Tenxor Wire Tensioner

TI2078/09, BML 08037

0730400

Reposition Clamp

TI2078/09

62-20125

Plate Cutting Pliers

TI2078/09

5057-6-300

Pin Cutter

TI2078/09

62-20295

Screwdriver Handle, revolving, rigid

TI2078/09

702628

Elastosil T-Handle

TI2078/09

6514-7-102

Luhr-Fritzemeier

TI1728/07

0193-3600

Large Locking Forceps

BSL Bioservice 084292 + 084293

704050

Omega3 TSP Aiming Block

BML08-041

702778

AxSOS Handle

BML08-216

13-19410

Scissors straight

TI2451/10

62-00082/ 62-00081

Activation Rod (MID II)

TI2262

62-50101

Quick Drive Mini

TI2076/09

1320-5340/ -50, -60

Gamma3 DTS Adjusting Device

240608CB9

69-1022074

T2 Guide Wire Pusher

SMP Report no 00810011401

SK1-913-07

One-Piece Target Sleeve

SMP Report no 04808011403

SK1-08-776

T2 Guide Wire Ruler

SMP Report no 16308012611

SK1-08-989

Gamma3 U-Blade Extractor

SMP Report no 18108012612

Group V – Flexible Instruments

Article number Description

Report

1150-0300

TI2078/09

Reamer Shaft

0227-8510

Flexible Reamer Shaft, 8mm

TI2078/09

1806-0073

Teflon Tube

TI2078/09

1320-0233

Gamma3 Flexible Screwdriver

MDS Test Report 081727-10-A and B, Test Report 230408CG1

Appendix 2 Group VI – Storage trays

Article number Description

Report

29-32400

Asnis Micro Tray

TI2078/09

29-13009

VariAx Hand level 4 container

TI2078/09

901585, 901587, Asnis III, 6.5 & 8.0 trays 901584, 901588

TI2078/09

902913

AxSOS Targeting 5.0mm instrument tray

TI2078/09

Inlays VariAx Hand

SMP report no. 09606011411

Screw Racks

TI1504/07

Inlays VariAx Foot

TI1504/07

29-30015

Silicone Mat

TI2042/09

902855

MMT VariAx Elbow EPS

150408CG1

902845

MMT AxSOS Targeting Proximal Lateral Tibia

210307CG3

902846

MMT AxSOS Targeting 4.0mm Instruments

210307CG3

1768F955

Asnis Micro Screw Rack

TI1424/07

1320-9550/ -60

Gamma3 DTS Tray R1.5/ R2.0

240608CB7

Group VII – Implants

Article number Description

Report

1732-1248 (S)

S2 Femoral Nail A/R, dia 12 × 480mm

TI2381/09

1832-3830 (S)

T2 Proximal Humerus Nail, long, dia 8 × 300mm

TI2381/09

1859-5120 (S)

Condyle Screw, dia 5 × 120mm

TI2381/09

436008

AxSOS Distal Radius Plate 3.0

TI2381/09

SHBIP9TS

Numelock II 4.5 Distal Medial Humerus Plate

TI2381/09

326780

Asnis III 8.0 / 180mm, St

TI2381/09

40-20230

Asnis Micro 2.0mm Cannulated Screw, length 30mm

TI2381/09

5425393

VariAx Distal Radius Universal Volar DR Plate, wide, extra long

TI2381/09

92-15904

Screw 1.5 × 4mm, self drilling (Neuro)

TI2381/09

50-20362

MMF Screw, self drilling 2.0 × 12mm

TI2381/09

55-10580

Locking Osteotomy Plate

TI2381/09

55-28934

Full Secondary Recon Plate

TI2381/09

55-28100

Condyle Prosthesis

TI2381/09

92-00647

Pre-bent Mesh for 1.7 / 1.9mm Screws

TI2381/09

629164, 629088

VariAx Elbow Plates

BML09-424

62-00435, 62-00420

MID Distractor

TI2262

340638

Cortex Screw S.T: 4.5 × 38mm

BML08-144

This list will be updated periodically. 15

Appendix 3 Guidelines to check proper functionality of the medical devices The following guidelines should be applied to all Stryker Osteosynthesis instruments which are labeled for multiple use. All functional checks and inspections described below also cover the interfaces with other instruments or components. The failure modes below may be caused by end of life of the product, improper use or improper maintenance.

Functional check for multiple use Drill Bits

Stryker Osteosynthesis does not usually define the maximum number of uses for re-usable medical devices. The useful life of these devices depends on many factors including the method and duration of each use, and the handling between uses. Careful inspection and functional test of the device before use is the best method of determining the end of serviceable life for the medical device. However, for certain instruments end of life has been defined, verified and specified with either a number of uses or an expiration date.

Coupling end eroded

Description and Function: Multiple use drill bits, cannulated drill bits, burrs, taps, core drills Typical Failure Modes: • Defective coupling end (eroded) • Blunt and dull cutting flutes • Tips, helix coil, bent Preventive Maintenance: Such instruments are recommended as single patient use. Regular functional check and visual inspection. In case of failure, the instrument must be replaced and not be used.

Blunt / dull tip Please check at tip of drill (see mark)

Dents on cutting flutes

Appendix 3 Drill Bit: Overview

Drill bit: twisted

Drill bit: blunt / dull cutting flutes

Drill bit: helix coil - the cutting flutes change direction

Drill bit: blunt / dull cutting flutes and helix

Appendix 3 Functional Check for Reamers

Description and Function: Intramedullery reamer, reamer heads, reamer shaft

Reamer shaft: deformed

Typical Failure Modes: • Defective coupling end • Blunt and dull cutting flutes • Tips, helix coil of reamer shaft deformed Preventive Maintenance: Regular functional check and visual inspection. In case of failure, the instrument must be replaced and not be used.

Reamer bit: blunt / dull cutting flutes

Chunking in cutting flutes

Blunt / dull cutting flutes and tip

Appendix 3 Functional Check for Screwdriver Blades

Description and Function: Screwdrivers with drive connections of various designs with or without selfretaining function.

Hexagon drive connection: fractured

Typical Failure Modes: • Deformation of the blade (twisted) • Deformation of the blade (rounded) • Breakage of the blade´s self-retaining mechanism without function • Corresponding drive connection of screw head is rounded or worn.

Hexagon drive connection: deformed

Preventive Maintenance: Use an appropriate instrument spray for the mechanism of the self-retaining screwdrivers. Regular functional check and visual inspection. Replace and do not use in case of failure. Regular functional check of corresponding items (screwdrivers - screws).

Hexagon drive connection: rounded

Appendix 3

Hexagon drive connection: deformed

Hexagon drive Gamma Lag Screwdriver for U-Blade: deformed and broken off pegs connection

Gamma Lag Screwdriver: deformed/ broken off pegs

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