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Reusable Instrument

Lifespan Manual

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INTRODUCTION

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This manual is intended to assist the user in determining whether a reusable instrument

has worn to an extent that it is no longer suitable for use. For additional reusable instrument

care instructions, see the Zimmer Instrument Care, Cleaning, Maintenance and Sterilization

Instructions (Doc No. 97-5000-170-00).

INTRODUC TION

Purpose

Scope

This manual provides information applicable to the reusable instruments used to implant hip, knee,

shoulder, elbow, ankle, and trauma implants. This information is NOT APPLICABLE to single use

instruments (sterile and non-sterile).

Glossary

Indicator – A term used to describe damage to a device that can indicate the instrument

is no longer suitable for use.

Feedback – Refers to any specific visual, auditory, or tactile feedback that serves as an indicator

of decision/action.

Quick Check – An assessment of the instrument’s condition to detect the presence of wear.

Reprocessing – The necessary validated processes including cleaning, disinfection, and

sterilization to render a medical device, which has been previously used or contaminated,

fit for its intended subsequent single use.

Understanding Document Structure

This manual describes several types of wear including:

i. Bending

ii. Discoloration

iii. Corrosion

iv. Fracture

v. Thread Damage

vi. Surface Damage

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The indicators identified above are signs of wear and damage on reusable instruments.

The manual is separated by the aforementioned indicators. Each indicator section contains:

INTRODUC TION

Understanding Document Structure (cont.)

• Images representing the indicator category to which it belongs. Images are only

a representation of possible wear.

• Descriptions of the indicator shown in the image and content specific to the indicator.

• Quick Check Methods to assist in assessing the instrument for the presence of said indicator.

• Potential Effects of Wear on any reusable instrument specific to the indicator described,

not particularly those shown in the images provided, to aid in assessing if the instrument

is suitable for use.

• Symbol legend

ü

Suitable for Use

X Not Suitable for Use

Inspection/Function Testing

While loading instruments into their respective instrument cases after cleaning and prior to

sterilization, reference the manual and follow the instructions below.

1. Instruments should be inspected for completeness and function.

2. Inspection includes:

a. Checking instruments that form part of a larger assembly or assemble

with mating components.

b. Checking internal mechanisms such as o-rings, springs, and subcomponents,

if the device is intended to be disassembled for proper reprocessing.

c. Actuating moving parts such as hinges/joints and moveable features

such as handles, ratcheting, couplings, and sliding parts.

d. Inspecting for all forms of wear outlined in this manual.

3. Results of assembly, actuation, and extent of all forms of wear should be considered

in determining whether an instrument is suitable for use.

4. If the reusable instrument is determined no longer suitable for use or if the suitability for use

is still in question after inspecting the instrument and referencing the Reusable Instrument

Lifespan Manual, initiate the process to return the instrument(s) to the manufacturer.

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If an allegation is made related to the identity, quality, durability, reliability, safety, effectiveness,

or performance of a device at any other time, please complete and submit a Product Experience

Report (CF04001) and return the reusable instrument(s) to the manufacturer for investigation.

INTRODUC TION

Returning the Reusable Instrument(s)

If the instrument to be returned is not a complaint, complete and submit a Worn Instrument

Return Form (F-01413 D).

The Worn Instrument Return Program is not a replacement for the Complaints Submission Process.

Please do not attempt to dispose of the reusable instrument(s) through any other means.

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BENDING

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X

ü

X

Description

Potential Effects of Wear

• Bent

• Inadequate force applied

• Kinked

• Inadequate engagement of components

• Crooked

• Inadequate disengagement of components

• Unraveled coils

• Inadequate reprocessing

Roll Quick Check –

Action: Instrument is rolled back and forth on flat surface.

Result: If instrument wobbles, wear is present and the

instrument must be returned to the manufacturer.

• Contact unintended soft tissue or bone

Inclined Quick Check –

Action: Instrument is rolled down an incline.

Result: If instrument does not roll freely, wear is present

and the instrument must be returned to the manufacturer.

• Inadequate application/removal of bone

cement

BENDING

ü

• Inaccurate feedback

• Inadequate removal of bone, soft tissue, or

bone cement to a specific/non-specific shape

Free End Lift Quick Check –

Action: Allow instrument to lay flat on a surface.

Result: If deflection is observed at the free end, wear is present

and the instrument must be returned to the manufacturer.

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BENDING

ü

X

Description

Potential Effects of Wear

• Bowed

• Inadequate force applied

• Curved

• Inadequate engagement of components

• Warped

• Inadequate disengagement of components

• Unraveled coils

• Inadequate reprocessing

Roll Quick Check –

Action: Instrument is rolled back and forth on flat surface.

Result: If instrument wobbles, wear is present and the

instrument must be returned to the manufacturer.

• Contact unintended soft tissue or bone

Inclined Quick Check –

Action: Instrument is rolled down an incline.

Result: If instrument does not roll freely, wear is present

and the instrument must be returned to the manufacturer.

• Inadequate application/removal of bone

cement

• Inaccurate feedback

• Inadequate removal of bone, soft tissue, or

bone cement to a specific/non-specific shape

Free End Lift Quick Check –

Action: Allow instrument to lay flat on a surface.

Result: If deflection is observed at the free end, wear is present

and the instrument must be returned to the manufacturer.

Camber Quick Check –

Action: Place instrument on a flat surface with either end

on a straight edge.

Result: If there is deflection in the width direction, wear is present

and the instrument must be returned to the manufacturer.

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X

ü

X

Description

Potential Effects of Wear

• Curled cutting edges

• Inadequate force applied

BENDING

ü

• Inadequate engagement of components

• Inadequate disengagement of components

• Inadequate reprocessing

• Contact unintended soft tissue or bone

• Inaccurate feedback

• Inadequate removal of bone, soft tissue, or

bone cement to a specific/non-specific shape

• Inadequate application/removal of

bone cement

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BENDING

ü

X

Description

Potential Effects of Wear

• Bent light pipe or cable

• Inadequate light for guidance

Light Quick Check –

Action: Hold end of light pipe or cable against a light source

and look into pipe or cable at the other end.

Result: If light will no longer travel through the pipe or cable,

wear is present and the instrument must be returned to the

manufacturer.

• Inadequate engagement of components

• Inadequate disengagement of components

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ü

X

X

Description

Potential Effects of Wear

Bent, bowed or warped:

• Cases

• Insufficient function of handles, lids,

and rotating components

• Bases

• Can allow free travel of contents

• Trays

• Interference between case components

and contents

• Lids

• Brackets or posts

BENDING

ü

• Inadequate reprocessing

• Inadequate engagement of components

• Inadequate disengagement of components

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D I S C O L O R AT I O N

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D I S C O L O R AT I O N

ü

X

Description

Potential Effects of Wear

• Discolored product markings

• Illegible product markings

Readability Quick Check –

Action: Read instrument markings.

Result: If instrument markings are illegible or difficult to read,

wear is present and the instrument must be returned to the

manufacturer.

• Inaccurate feedback

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D I S C O L O R AT I O N

ü

X

Description

Potential Effects of Wear

• Discolored product markings due to corrosion

• Illegible product markings

Pencil Eraser Quick Check –

Action: Rub a pencil eraser on the affected area.

If the discoloration is removed by the eraser, it is a stain.

Result: If the discoloration is not removed by the eraser

or reveals pitting, wear is present and the instrument

must be returned to the manufacturer.

• Inaccurate feedback

Readability Quick Check –

Action: Read instrument markings.

Result: If instrument markings are illegible or difficult to

read, wear is present and the instrument must be returned

to the manufacturer.

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CORROSION

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X

ü

X

Description

Potential Effects of Wear

• Surface corrosion

• Inaccurate feedback

• Pitting

• Inadequate reprocessing

Pencil Eraser Quick Check –

Action: Rub a pencil eraser on the affected area.

If the discoloration is removed by the eraser, it is a stain.

Result: If the discoloration is not removed by the eraser

or reveals pitting, wear is present and the instrument

must be returned to the manufacturer.

• Inadequate removal of bone, soft tissue, or

bone cement to a specific/non-specific shape

CORROSION

ü

• Inadequate engagement of components

• Inadequate disengagement of components

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X

ü

X

Description

Potential Effects of Wear

• Crevice corrosion

• Inaccurate feedback

• External/Internal thread corrosion

• Inadequate reprocessing

Threading Quick Check –

Action: Thread the components.

Result: If there is difficulty fastening or unfastening components,

wear is present and the instrument must be returned to the

manufacturer.

• Inadequate engagement of components

Pencil Eraser Quick Check –

Action: Rub a pencil eraser on the affected area.

If the discoloration is removed by the eraser, it is a stain.

Result: If the discoloration is not removed by the eraser

or reveals pitting, wear is present and the instrument

must be returned to the manufacturer.

• Excessive torque to disengage threads

CORROSION

ü

• Inadequate disengagement of components

• Inadequate removal of bone, soft tissue, or

bone cement to a specific/nonspecific shape

• Excessive torque to engage threads

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CORROSION

ü

X

Description

Potential Effects of Wear

• Discolored product markings due to corrosion

• Illegible product markings

Pencil Eraser Quick Check –

Action: Rub a pencil eraser on the affected area.

Result: If the discoloration is removed by the eraser, it is a stain.

If the discoloration is not removed by the eraser or reveals

pitting, wear is present and the instrument must be returned

to the manufacturer.

• Inaccurate feedback

Readability Quick Check –

Action: Read instrument markings.

Result: If instrument markings are illegible or difficult to read,

wear is present and the instrument must be returned to the

manufacturer.

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FR ACTURE

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FR AC TURE

ü

X

Description

Potential Effects of Wear

• Fractured

• Inadequate reprocessing

• Inadequate accommodation of hand use

• Inadequate force applied

• Inaccurate feedback

• Inadequate engagement of components

• Inadequate disengagement of components

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X

ü

X

Description

Potential Effects of Wear

• Cracked

• Inadequate reprocessing

FR AC TURE

ü

• Inadequate accommodation of hand use

• Inadequate force applied

• Fracture

• Inaccurate feedback

• Inadequate engagement of components

• Inadequate disengagement of components

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FR AC TURE

ü

X

Description

Potential Effects of Wear

• Cracked/Fractured in flexible shaft body

• Inadequate reprocessing

• Inadequate accommodation of hand use

• Inadequate force applied

• Fracture

• Inaccurate feedback

• Inadequate engagement of components

• Inadequate disengagement of components

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THRE AD DAMAGE

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X

ü

X

Description

Potential Effects of Wear

• Stripped external/internal threads

• Excessive torque to engage threads

• Damaged external/internal threads

• Excessive torque to disengage threads

Threading Quick Check –

Action: Thread the components.

Result: If there is difficulty fastening or unfastening

components, wear is present and the instrument

must be returned to the manufacturer.

• Inaccurate feedback

T H R E A D DA M A G E

ü

• Inadequate engagement of components

• Inadequate disengagement of components

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