SLI0001 Instructions for Inspection and Maintenance of Reusable Medical Devices

Labeling symbols Labeling symbols

The following is a list of symbols that may be used on Howmedica Osteonics Corp, herein known as Stryker Orthopaedics, medical device labeling. Refer to individual product labels for applicable symbology for each product. Symbol Caution (See instructions for use for operator awareness)

Consult instructions for use or consult electronic instructions for use Do not re-use Non-sterile

Date of manufacture Legal manufacturer

Authorized representative in the European Community Catalogue number Batch code

Serial number

Do not use if package is damaged Medical device Quantity

"Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician" Unique device identifier

Table of contents

Standard ISO 15223-1

Introduction

ISO 15223-1

Warnings and precautions

ISO 15223-1

Device markings

Reusable instrument inspections

ISO 15223-1

Trials

ISO 15223-1

Broaches and chisels

ISO 15223-1

Drills, inserters, reamers, and threads Rods, guides, measurement, and alignment Assembly and connection mechanisms

ISO 15223-1 ISO 15223-1 ISO 15223-1 ISO 15223-1

Handles

ISO 15223-1 ISO 15223-1

Impactors and impactor handles

-----

Cases, trays, and lids

Wrenches

-----

Templates

ISO 15223-1 2

Table of contents Labeling symbols

Introduction ... 4 Warnings and precautions ... 5 Reusable instrument inspections ... 6 1. Device markings ... 7 2. Trials ... 8 3. Broaches and chisels ...12 4. Drills, inserters, reamers, and threads ... 15 5. Rods, guides, measurement, and alignment ... 19 6. Assembly and connection mechanisms ... 23 6.1. Lubrication of instruments... 23 7. Handles ...27 8. Impactors and impactor handles ... 29 9. Wrenches ...31 10. Cases, trays, and lids ...32 11. Templates ... 36

Table of contents

Introduction

Warnings and precautions Reusable instrument inspections Device markings Trials

Broaches and chisels

Drills, inserters, reamers, and threads Rods, guides, measurement, and alignment Assembly and connection mechanisms Handles

Impactors and impactor handles Wrenches

Cases, trays, and lids Templates

3

Introduction Labeling symbols

Howmedica Osteonics Corp (herein referred to as Stryker Orthopaedics) invasive instrumentation consists of surgical instruments intended for use during hip, knee, and osteosyntheses orthopedic surgeries. Generic, hand-held orthopaedic instrumentation examples include, but are not limited to, retractors, inserters, and impactors, in addition to positioning, trialing, measuring, and attached to power instruments.

Table of contents

Introduction

Purpose: All Stryker Orthopaedics reusable instruments must be inspected to prepare them for use. The purpose of this e-IFU is intended to provide detailed instructions for inspection and maintenance of reusable surgical instruments manufactured by Stryker Orthopaedics and to determine when an instrument has reached the end of its serviceable life and must be replaced.

Warnings and precautions Reusable instrument inspections

Examination prior to use: Instruments should be examined for wear and damage by physicians, surgical staff, and reprocessing staff prior to and after each surgery to determine if the instrument needs lubrication and/ or if the instrument is still in a condition to be re-used. The examination should include a visual and functional inspection of the working surfaces, articulation points, rotating features, hinges, springs, connection mechanisms, mating parts, threads, and working ends of all instruments. Functional inspections may replicate aspects of the intended use of the device to confirm the instrument moves, assembles, disassembles, locks, unlocks, and/or rotates as expected.

Device markings Trials

Broaches and chisels

Drills, inserters, reamers, and threads Rods, guides, measurement, and alignment Assembly and connection mechanisms

Stryker Orthopaedics and its representatives are available to help answer questions regarding proper instrument inspections and to help assess if a device has reached its end of serviceable life. Stryker Orthopaedics will not be held responsible for the use of instruments that are damaged, incomplete, show signs of excessive wear and tear, or that have been repaired or sharpened outside the control of Stryker Orthopaedics. Any faulty instruments must be replaced prior to any intervention or surgical procedure.

The instructions for use, operative techniques, cleaning instructions, patient information leaflets and other associated labeling may be requested online at www.ifu.stryker.com, www.stryker.com or www.patientinfo.stryker.com.

Handles

Impactors and impactor handles Wrenches

Cases, trays, and lids Templates

4

Warnings and precautions Labeling symbols

1. Single-use devices must not be reused, as they are not designed to perform as intended after the initial use, unless they are reprocessed by a re-processor expressly authorized by Stryker Orthopaedics. Only then can it be assured that the device is appropriate for reprocessing and that the correct methods of validation are used. Please refer to the device label to identify single- or multiple-use devices and components.

Table of contents

Introduction

2. Some device materials may develop changes in mechanical, physical, or chemical characteristics under conditions of repeated use, cleaning and re-sterilization that may compromise the integrity of the design and/or material leading to diminished safety, performance and/or compliance with relevant specifications. Refer to reference e-IFU LSTPI-B “Cleaning, Sterilization, Inspection and Maintenance of Reusable Medical Devices” for additional information regarding cleaning and sterilization. This e-IFU is available at ifu.stryker.com.

Warnings and precautions Reusable instrument inspections

3. Reusable instruments should be inspected for damage, due to wear, before and after each use. Damage can result in metal or polymer material release while in use or damage to the bone during preparation. Damage to mating features may impact the instrument’s output or functionality, its ability to assemble and disassemble, and ability to lock and unlock.

Device markings Trials

4. Instruments should not be used past the end of their serviceable life or with a failure mode present. The use of an instrument past its end serviceable of life (with a failure mode present) could potentially lead to extended surgery, infection, inflammation, an allergic reaction, soft tissue and/ or bone damage, or damage to the operator’s personal equipment, for example gloves.

Broaches and chisels

Drills, inserters, reamers, and threads Rods, guides, measurement, and alignment Assembly and connection mechanisms

5. Due to different manufacturers employing differing design parameters, varying tolerances, different materials, and manufacturing specifications, Stryker Orthopaedics instrumentation should not be used to implant any other manufacturer’s components. Any such use will negate the responsibility of Stryker Orthopaedics for the performance of the resulting implant.

6. Care must be taken when handling any sharp-edged orthopaedic device

7. After cleaning or during inspection activities, instruments with moving parts or assemblies may require application of biocompatible medical grade lubricants, per ISO 10993. Lubrication is part of preventive maintenance and may be needed on a regular basis to ensure instruments are working at their maximum potential. The regular use of instrument lubricant will eliminate binding and keep surgical instruments operating freely and easily. Use only moist-heat compatible medical grade lubricants prior to sterilization. See 6. Assembly and connection mechanisms for further inspection detail.

Handles

Impactors and impactor handles

End of useful life statement: The actual useful life of a device depends on many additional factors, including expertise and training of the person who uses it, the conditions of use, the method and duration of each use, and the precautions taken in handling, cleaning, and storage.

Care must be taken of the instruments to ensure that they remain in good working order. Careful inspection and functional testing of devices before and after use is the best method of determining the end of serviceable life for a reusable medical device. Please see details in this document to determine the conditions that make a device useable or conditions often seen at the end of its service.

Wrenches

Cases, trays, and lids Templates

5

Reusable instrument inspections Labeling symbols

Reusable instruments are devices with more than one use during their time of service. These instruments help in bone preparation, assembly, trialing, and implantation of joint replacement medical devices, as well as devices for primary, revision, total, and partial arthroplasty procedures. Reusable instruments should be examined for wear and damage by surgical staff, service personnel, and reprocessing staff, prior to and after each surgery, to determine if the instrument needs lubrication and/ or if the instrument is still in a condition to be re-used.

Table of contents

Introduction

The sections below are arranged by device functionality and show recommended inspections for reusable instruments. The categories covered are: 1. 2. 3. 4. 5. 6.

7. 8. 9. 10. 11.

Warnings and precautions Reusable instrument inspections

Device markings Trials Broaches and chisels Drills, inserters, reamers, and threads Rods, guides, measurement, and alignment Assembly and connection mechanisms 6.1. Lubrication of instruments Handles Impactors and impactor handles Wrenches Cases, trays, and lids Templates

Device markings Trials

Broaches and chisels

Drills, inserters, reamers, and threads Rods, guides, measurement, and alignment Assembly and connection mechanisms

All inspections and functional checks should be performed in a well-lit area, after cleaning and sterilization but prior to use.

If any of the failure modes outlined in this document are identified, the instrument has reached its end of service. The instrument must be returned to Stryker Orthopaedics, and a product complaint must be submitted per local procedures. Stryker Orthopaedics shall not be responsible in the event of the use of instruments that are damaged, incomplete, show signs of excessive wear and tear, or that have been repaired or sharpened outside of the control of Stryker. Any faulty instruments must be replaced prior to any surgical procedure.

Handles

Use of an instrument past its serviceable life may result in instrument failure, failure to assemble, failure to disassemble, device disassociation, incorrect or inappropriate output or functionality, harm to the user during handling, and/ or excessive material release in the form of polymer, metal shavings, fragments, or particulates.

Impactors and impactor handles Wrenches

Cases, trays, and lids Templates

6

1. Device markings Labeling symbols

Visual inspection: a. Ensure that any markings such as markings that identify the product (catalog number), lot number, and any additional information that indicates left/ right or identify the size are clearly legible.

Table of contents

Introduction

b. For instruments with a measuring function, ensure markings are present and clear. Illegible or damaged markings may prevent use and lead to inaccurate measurements.

Warnings and precautions

c. Inspect for excessive corrosion and discoloration that may result in the loss of markings, illegible markings, and the generation of particulates.

Reusable instrument inspections Device markings Trials

Figure 1: Guide with legible measurement markings

Figure 2: Discolored instrument tray

Figure 3: Illegible laser markings

Figure 4: Worn/ illegible instrument markings

Broaches and chisels

Drills, inserters, reamers, and threads Rods, guides, measurement, and alignment Assembly and connection mechanisms Handles

Impactors and impactor handles Wrenches

Cases, trays, and lids Figure 5: Discolored/ illegible instrument markings

Templates

7

2. Trials Labeling symbols

Visual inspection: a. Check to ensure there are no burrs, embedded material, or trapped material, as this may cause difficulty in cleaning the instrument, as well as the release of material debris.

Table of contents

Assembly and mechanism functional check: a. Trials meant to replicate joint movement should be smooth to operate, without binding or tight spots caused by surface damage, missing material, or fractures. Trials may inevitably show signs of wear; however, no roughness or sharp burrs can be allowed on any surface that meets with instruments or other components.

Introduction

Warnings and precautions Reusable instrument inspections

b. Check that trial movement is smooth and not impeded in such a way that prevents the device from replicating the corresponding implant form and function. If trialing is not possible or if movement is not smooth, check for signs of wear, deformation, dissociation, or damage on articulating surfaces or moveable parts.

Device markings

c. Check trial fit to ensure that the device can assemble and disassemble. Check that the fit is not too loose, too tight, or unable to fit.

Trials

Tactile inspection: a. Instruments may develop surface scratches with use, which is expected. However, cracks and fractures are not acceptable (Figures 19a and 19b).

Figure 6a: Triathlon TS offset adapter

Broaches and chisels

Drills, inserters, reamers, and threads Rods, guides, measurement, and alignment Assembly and connection mechanisms

Figure 6b: Damaged Triathlon TS offset adapter

Handles

Impactors and impactor handles Wrenches

Figure 7: Tibial trial damage

Cases, trays, and lids

Figure 8: Trial surface damage

Templates

8

2. Trials Labeling symbols

Table of contents

Introduction

Warnings and precautions Reusable instrument inspections

Figure 9: Surface damage on outside of trial

Device markings

Figure 10: Surface damage on underside of trial

Trials

Broaches and chisels

Figure 11: Surface damage on window trial

Drills, inserters, reamers, and threads Rods, guides, measurement, and alignment Assembly and connection mechanisms Handles

Figure 12: Surface damage on underside of window trial

Impactors and impactor handles Wrenches

Cases, trays, and lids Templates

9

2. Trials Labeling symbols

Table of contents

Introduction

Warnings and precautions

Figure 13: Partial dissociation of ring inside of trial

Reusable instrument inspections Device markings

Figure 14: Material deformation inside of trial

Trials

Broaches and chisels

Figure 15a: Ensure that trial markings are readable; Check for material delamination or damage

Drills, inserters, reamers, and threads Rods, guides, measurement, and alignment Assembly and connection mechanisms

Figure 15b: C-ring is not broken

Handles

Impactors and impactor handles Wrenches

Figure 16a: Hairline cracks on tibial trial

Cases, trays, and lids

Figure 16b: Close-up of hairline cracks on tibial trial

Templates

10

2. Trials Labeling symbols

Table of contents

Introduction

Warnings and precautions Figure 17: Embedded material inside of trial

Reusable instrument inspections

Figure 18: Burring on trial that may result in material release

Device markings Trials

Broaches and chisels

Figure 19a: Tactile inspection: 1. Slide a fingernail on the surface of the instrument. 2. If the fingernail is obstructed and/ or resisted, check for the presence of damage, cracks, or fractures.

Drills, inserters, reamers, and threads Rods, guides, measurement, and alignment Assembly and connection mechanisms

Figure 19b: Tactile inspection: 1. Slide a fingernail on the surface of the instrument. 2. If the fingernail is obstructed and/ or resisted, check for the presence of damage, cracks, or fractures.

Handles

Impactors and impactor handles Wrenches

Cases, trays, and lids Templates

11

3. Broaches and chisels Labeling symbols

Visual inspection: a. Inspect cutting edges for dulling, loss of form, burring, or damage. Cutting edges need to be crisp and unbroken to prevent excessive stress in bone and soft tissue, as well as to prevent incorrect bone preparation.

Table of contents

Introduction

b. Instruments having discrete teeth for cutting should be checked to ensure that all teeth are intact and not bent or missing.

Warnings and precautions

c. Inspect the tips of inserters, introducers, retractors, impactors, starters, or any instrument intended to interact with bone or an implant for damage and deformation.

Reusable instrument inspections

d. Inspect for surface damage, as well as the generation of polymer or metal shavings, fragments, or particulates that may result in the release or transfer of material or fragments during use.

Device markings

Bending inspection: a. Lay cutting instruments on a flat surface, and check for signs of excessive bending, bowing, or warping that may result in loss of device functionality or excessive stress in bone.

Trials

Assembly and mechanism functional check: a. If instrument movement is impeded, check for signs of wear, deformation, or damage on articulating surfaces or moveable parts.

Broaches and chisels

Drills, inserters, reamers, and threads Rods, guides, measurement, and alignment Assembly and connection mechanisms

b. Sliding and articulating joints should be smooth to operate without binding or tight spots. The fit should not be so loose as to allow excessive movement, other than in the directions intended.

c.

Inspect instruments for missing and deformed components, to ensure that the instruments can assemble and disassemble with their corresponding mating instruments and adapters.

Handles

Figure 20a: Fractured cable cutter

Impactors and impactor handles Wrenches

Figure 20b: Fractured cutting edge (close-up)

Cases, trays, and lids Templates

12

3. Broaches and chisels Labeling symbols

Table of contents

Introduction

Warnings and precautions

Figure 21: Damaged chisel tip

Reusable instrument inspections Device markings

Figure 22: Cracked chisel tip

Trials

Broaches and chisels

Figure 23a: Damaged chisel

Drills, inserters, reamers, and threads Rods, guides, measurement, and alignment Assembly and connection mechanisms

Figure 23b: Edge damage and deformation

Handles

Figure 24a: Dented chisel cutting edge (front view)

Impactors and impactor handles Wrenches

Figure 24b: Dented chisel cutting edge (side view)

Cases, trays, and lids Templates

13

3. Broaches and chisels Labeling symbols

Table of contents

Introduction

Warnings and precautions Figure 25a: Broach surface chipping

Reusable instrument inspections

Figure 25b: Broach surface chipping (close-up)

Device markings Trials

Broaches and chisels

Drills, inserters, reamers, and threads Rods, guides, measurement, and alignment Assembly and connection mechanisms Handles

Impactors and impactor handles Wrenches

Cases, trays, and lids Templates

14

4. Drills, inserters, reamers, and threads Visual inspection: a. The cutting tips of drills must have a crisp edge. If cutting edges appear rounded, flattened and/ or polished on the top face, worn and incomplete on the corner, or if any damage is present the drill must be discarded. b. Cutting flutes must be inspected for a change in direction, blunt or dull helixes, twisted drill bits, damaged drill tips, and dents.

Table of contents

Introduction

Warnings and precautions

c. Inspect the tips of driving instruments or any instrument intended to interact with bone or an implant for damage and deformation.

Reusable instrument inspections

Bending inspection: a. Inspect long cylindrical instruments for excessive bending, bowing, or warping (Figures 37a, 37b, 38a, 38b, 39, and 40) that may result in excessive stress in bone or damage to other instruments such as guides.

Device markings Trials

Assembly and mechanism functional check: a. Screw threads can easily be damaged. Where possible, mating components should be checked for fit, which will be smooth and free running. Any tightness or binding may be a sign of damage or contamination and a reason for rejection.

b. If threads are present, check the threading of the components. If there is difficulty assembling or disassembling components check for signs of wear, deformation, or damage. Devices should be able to be fully threaded. Where trial assembly with the mating component is not possible, the use of a test piece, kept by the inspector for this purpose, is recommended.

Figure 26a: Damaged femoral head extractor

Labeling symbols

Broaches and chisels

Drills, inserters, reamers, and threads Rods, guides, measurement, and alignment Assembly and connection mechanisms Handles

Impactors and impactor handles

Figure 26b: Close-up of damaged femoral head extractor

Wrenches

Cases, trays, and lids Templates

15

4. Drills, inserters, reamers, and threads Labeling symbols

Table of contents

Figure 27a: Blunt/ dulling cutting flute

Introduction

Figure 27b: Close-up of blunt/ dulling cutting flute

Warnings and precautions Reusable instrument inspections Device markings Trials

Broaches and chisels

Figure 28: Fractured cutting surface

Drills, inserters, reamers, and threads Rods, guides, measurement, and alignment Assembly and connection mechanisms

Figure 29: Internal thread damage on tibial baseplate

Handles

Figure 30: Cup impactor thread damage

Impactors and impactor handles Wrenches

Figure 31: Cup impactor thread damage

Cases, trays, and lids Templates

16

4. Drills, inserters, reamers, and threads Labeling symbols

Table of contents

Introduction

Figure 32: Galling and contact damage

Figure 33: Galling and contact damage (close-up)

Warnings and precautions Reusable instrument inspections Device markings Trials

Figure 34: Deformed headless pin tip

Figure 36a: Screwdriver tip wear

Broaches and chisels

Figure 35: Screwdriver tip fracture

Drills, inserters, reamers, and threads Rods, guides, measurement, and alignment Assembly and connection mechanisms Handles

Impactors and impactor handles

Figure 36b: Close-up of screwdriver tip wear

Wrenches

Cases, trays, and lids Templates

17

4. Drills, inserters, reamers, and threads Labeling symbols

Table of contents

Introduction

Warnings and precautions Figure 37a: Roll inspection test (side view): 1. Place the instrument on a flat surface. 2. Roll the instrument across the surface. 3. If the instrument does not roll smoothly, deformation or damage may be present.

Figure 38a: Bent extractor tip

Figure 39: Bent drills, pins, and headless pins test steps: 1. Place the instrument on a flat surface. 2. Roll the instrument across the surface. 3. If the instrument does not roll smoothly, deformation or damage may be present

Reusable instrument inspections

Figure 37b: Roll inspection test (top view): 1. Place the instrument on a flat surface. 2. Roll the instrument across the surface. 3. If the instrument does not roll smoothly, deformation or damage may be present.

Device markings Trials

Broaches and chisels

Drills, inserters, reamers, and threads Rods, guides, measurement, and alignment Assembly and connection mechanisms

Figure 38b: Close-up of bent extractor tip

Handles

Figure 40: Bent drills, pins, and headless pins test steps: 1. Place the instrument on a flat surface. 2. Roll the instrument across the surface. 3. If the instrument does not roll smoothly, deformation or damage may be present

Impactors and impactor handles Wrenches

Cases, trays, and lids Templates

18

5. Rods, guides, measurement, and alignment

Labeling symbols

Table of contents

Visual inspection: a. Inspect for the presence of unraveled spiral elements and coils that may enable soil penetration. This may lead to difficulty in cleaning and sterilizing a device, due to soil or particulate buildup in the affected areas.

Introduction

Warnings and precautions

b. For components in contact with cutting instruments, such as saw guides or drill guides, scoring and scratches are expected and are permissible. However, check internally for excessive burrs or deformation, as it may result in damage to the cutting edge of the instrument. Fragments may become detached, due to the action of the cutting tool.

Reusable instrument inspections

c. Inspect for surface damage, as well as the generation of polymer, metal shavings, fragments, or particulates that may result in the release or transfer of material or fragments during use.

Device markings

Bending inspection: a. Inspect long cylindrical instruments for excessive bending, bowing, or warping that may result in excessive stress in bone. Place the instrument on a flat surface, roll the instrument across the surface, and if the instrument does not roll smoothly, wear or damage may be present.

Trials

Broaches and chisels

b. If the instrument’s design does not allow for smooth rolling, lay the instrument on a flat surface, and check for signs of excessive bending, bowing, or warping that may result in loss of device functionality or excessive stress in bone (Figure 53a, 53b, 53c).

Drills, inserters, reamers, and threads Rods, guides, measurement, and alignment Assembly and connection mechanisms

Assembly and mechanism functional check: a. For alignment instruments, ensure there is no deformation, and that the devices can be attached to mating instruments and assemblies. b. If there is evidence of excessive scoring or wear the fit with the mating instrument should be checked. The fit should allow free movement, without excessive angular play.

c. For pins, drills, and saw blades, ensure the device can go through the corresponding pin holes or cavities in the mating devices.

Handles

Tactile inspection: a. Instruments may develop surface scratches with use, which is expected. However, cracks and fractures are not acceptable (Figures 52a, 52b).

Impactors and impactor handles Wrenches

Cases, trays, and lids Templates

19

5. Rods, guides, measurement, and alignment

Labeling symbols

Table of contents

Introduction

Figure 41a: Proximal rod

Warnings and precautions Reusable instrument inspections

Figure 41b: Ensure levers can be actuated

Device markings Trials

Broaches and chisels

Figure 42: Proximal rod unable to assemble (arrows) due to fractured dowel pin weld (circle)

Drills, inserters, reamers, and threads Rods, guides, measurement, and alignment Assembly and connection mechanisms

Figure 43: Unraveled coil

Handles

Figure 44: Deformation/ burring present on cutting guides may break loose or damage cutting blades

Impactors and impactor handles

Figure 45: Burrs present on cutting guide

Wrenches

Cases, trays, and lids Templates

20