Reusable Instruments End of Life Indicators (EOLi) PDF download

Functional Control Document End of Life Indicators (EOLi) of Reusable Instruments This instruction for use is not intended for distribution in the USA.

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Important note for medical professionals and OR staff: This document does not include all the information necessary for selection and use of a device. Please read the instructions for use and the DePuy Synthes brochure “Important Information” carefully before use. Ensure that you are familiar with the appropriate surgical procedure.

Purpose The purpose of this document is to provide visual and functional information (i.e., End of Life Indicators) to the intended user to identify when the device should no longer be reused. In addition, this document provides recommended care information which may help to prevent or delay occurrence of the listed EOLi; however, devices that exhibit EOLi are not fit for use any longer. Consult your local Depuy Synthes representative to replace the device.

Basic Instructions for Using the End of Life Indicator (EOLi) Document

End of Life (EOL) of a device is normally determined by wear and damage due to use. Evidence of damage and wear on a device may include but is not limited to the EOLi contained within this document. DePuy Synthes instruments should be inspected for the applicable EOLi of the device after processing but prior to sterilization. This document contains representative images of the device type. It captures common design features within the device type that are pertinent to the function and safe use of the device. Each device may have one or more criteria provided that can be used to determine if the device is still within the recommended limits of its intended use (i.e., “Serviceable Device”), indicated by a green checkmark in the box in the lower right side of the picture, or outside its recommended limits of its intended use (i.e., “Defective Device”), indicated by a red ‘X’ in the box in the lower right side of the picture. When using this document, it is important to focus on the descriptive words for each feature as opposed to the accompanying picture only, as the picture is intended to document representative examples of types of wear and can therefore be applicable to multiple devices.

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Table of Contents

1.0

Generic EOLi (As Applicable)

2.0

1.1

Corrosion, Rusting, Pitting

1.2

Discoloration/Fading

2.1 Instruments With Spring-Loaded Ball Bearings

1.3

Excessive Scratches; Dents

2.2 Instruments With Hexagon Sockets or Bolt Heads

1.4

Flaking/Peeling

2.3

Instruments With Cams

1.5 Devices With Unrecognizable Markings; Etches/Buffed off or Missing Part Numbers

2.4

Instruments With Shanks or Sleeves

1.6

Cracks

2.6 Instruments With Interlocking Threads

1.7

Broken (2+ Pieces)

2.7

Instruments With Plastic Handles

1.8

Bent/Deformed/Twisted

2.8

Anodized Aluminum Items

1.9

Seized (Multi-Component Device)

2.9 Instruments With Coupling Features (e.g., Quick Coupling)

1.10 Seized (2+ Instruments) 1.11 Missing Components; Assembly/Disassembly 1.12 UDI Marking Unable to be Read

Feature EOLi (As Applicable)

2.5 Threaded Instruments

2.10

Plastic Items and Rubber Hoses

2.11

Compressed Air Hose Couplings

2.12

Instruments With Chuck

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Table of Contents (continued)

Device Type 3.0 Cable and Wire Instruments

19.0 Length Assessing Devices

4.0 Cases

20.0 Light Cables

5.0 Cleaning Instruments

21.0 Needles1

6.0 Cutting and Bone Removal Instruments

22.0 Plate Bending and Cutting Instruments

7.0 Distractors1

23.0 Reamer/Irrigator/Aspirator1

8.0 Drills/Protection Guides/ Sleeves/ Cannulas/Trocars

25.0 Reaming Rods1

9.0 Drill Bits

26.0 Reduction Instruments (Forceps, Compression Screw, Distractors)1

10.0 External Fixators1 11.0

Extraction Screws1

12.0 Forceps, Pliers, and Holding Instruments

27.0 Retractors/Elevators 28.0 Screwdrivers

13.0 Gauges/Calipers1

24.0 Reamers and Awls

29.0 Screwdriver Handles/Shafts1

14.0 Guiding Blocks and Aiming Instruments

30.0 Syringe1

15.0 Hammers1

31.0 Taps 1

16.0 Implant/Bending Templates

32.0 Torque Limiting Instruments1,2

17.0 Insertion and Extraction Instruments

33.0 Wires

18.0 Instrument Handles1

34.0 Wrenches

1.There are no unique EOLi for this device type – see Generic and Feature indicators, as applicable. 2. T orque Limiting devices require periodic maintenance and calibration to ensure that the device is performing as intended. Refer to device specific IFU to determine service frequency and other applicable information. If the audible click stops functioning or other concerns regarding functional performance, immediately return and replace the device to your DePuy Synthes representative.

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1.0 Generic EOLi (As Applicable)

1.1

Corrosion, Rusting, Pitting

X

EOLi

Recommended Care

• Corrosion that effects traceability or functionality, corrosion on patient contact surfaces

• Follow “Important Information” for reprocessing instructions of reusable devices

X

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1.0 Generic EOLi (As Applicable) 1.2 Discoloration/Fading

X

EOLi

Recommended Care

• Discoloration on plastic, anodized (i.e., color coded) aluminum and titanium devices

• Follow “Important Information” for reprocessing instructions of reusable devices

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1.0 Generic EOLi (As Applicable) 1.3 Excessive Scratches, Dents

X

EOLi • Excessive scratches or dents on surfaces that mate with other instruments or surfaces held by the user (e.g., handles) • Creation of burrs

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1.0 Generic EOLi (As Applicable) 1.4 Flaking/Peeling

X

EOLi

• Paint coating peels off (e.g., color-coded devices and graphic cases)

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1.0 Generic EOLi (As Applicable) 1.5 Devices With Unrecognizable Markings, Etches/Buffed off or Missing Part Numbers

X

EOLi

• Scratches, fading, anodization

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1.0 Generic EOLi (As Applicable) 1.6 Cracks

X

EOLi • Cracks at welded joints, cracks at assembly joints (e.g., pins), cracks in cannulated devices (e.g., threads, screwdriver tips)

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1.0 Generic EOLi (As Applicable)

1.7 Broken (2+ Pieces)

X

EOLi • Broken at welded joints, driver/tip breakage, broken at assembly joints (e.g., plastic handles)

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1.0 Generic EOLi (As Applicable) 1.8 Bent/Deformed/Twisted

X

EOLi

• Bent shaft or body, tips/drivers deformed or twisted

12

1.0 Generic EOLi (As Applicable) 1.9 Seized (Multi-Component Device)

X X X X

X

P

X X

P

EOLi

Recommended Care

• Restricted range of motion • Will not open or close

• Clean and lubricate hinges and joints

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1.0 Generic EOLi (As Applicable) 1.10 Seized (2+ Instruments)

X

EOLi • Seized coupling, bent shaft or deformed holes, threads deformed or stripped

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1.0 Generic EOLi (As Applicable) 1.11 Missing Components; Assembly/Disassembly Disassembled devices should be reassembled prior to sterilization unless otherwise noted or the case is not configured. Further detailed instrument dismantling instructions are available from your local sales representative or for download at http://emea.depuysynthes.com/hcp/reprocessing-care-maintenance.

1.12 UDI Marking Unable to be Read 2

1

X

2

P EOLi

Recommended Care

• Scanner does not read/recognize the UDI marking

• A Direct Part Marking (DPM) scanner is required. Prior to replacing the device, try scanning another device, clean the part surfaces, adjust the scan distance/angle, or adjust lighting distance/angle

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2.0 Feature EOLi (As Applicable) 2.1

Instruments With Spring-Loaded Ball Bearings

X

P

EOLi

Recommended Care

• Ball-bearing jammed

• Lubricate as needed

• Ball-bearing lost

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2.0 Feature EOLi (As Applicable) 2.2 Instruments With Hexagon Sockets or Bolt Heads

X

P

X

EOLi • Hexagon bolt head worn or damaged • Hexagon socket widened

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2.0 Feature EOLi (As Applicable) 2.3 Instruments With Cams

X

P

X

EOLi • Cams bent, twisted or broken off • Misalignment between mating features

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2.0 Feature EOLi (As Applicable) 2.4 Instruments With Shanks or Sleeves

P

EOLi

• Shank or sleeve bent or blocked

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2.0 Feature EOLi (As Applicable)

2.5 Threaded Instruments

X

EOLi

Recommended Care

• Difficulty in screwing in and unscrewing

• Remove any incrustations with a suitable detergent. Then carefully clean instrument and apply lubrication regularly

• Threads damaged/peeling

• Clean the threads carefully. Always fully unscrew the screws • Do not use excessive force

P

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DePuy Synthes

ACETABULAR CEMENT PRESSURIZER HNDL

Reusable Instruments End of Life Indicators (EOLi)