zimmer_biomet_reusable_instrument_lifespan_manual__.pdf
Page 1
Reusable Instrument
Lifespan Manual
Page 2
Table of Contents
Introduction............................................................................................................... 3
Bending...................................................................................................................... 7
Discoloration............................................................................................................ 13
Corrosion................................................................................................................. 16
Fracture.................................................................................................................... 20
Thread Damage....................................................................................................... 24
Surface Damage...................................................................................................... 27
Page 3
INTRODUCTION
3
Page 4
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
4
Page 5
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.
5
Page 6
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.
6
Page 7
BENDING
7
Page 8
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.
8
Page 9
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.
9
Page 10
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
10
Page 11
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
11
Page 12
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
12
Page 13
D I S C O L O R AT I O N
13
Page 14
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
14
Page 15
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.
15
Page 16
CORROSION
16
Page 17
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
17
Page 18
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
18
Page 19
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.
19
Page 20
FR ACTURE
20
Page 21
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
21
Page 22
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
22
Page 23
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
23
Page 24
THRE AD DAMAGE
24
Page 25
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
25