Swemac Inspection Instructions

Swemac Inspection Instructions Purpose These instructions were developed to comply with the requirements of 2017/745 MDR and are intended to assist healthcare professionals in establishing a safe handling routine for inspection of Swemac reusable surgical instruments. A thorough inspection is crucial in order to have instruments which will function as intended. Before preparing for sterilisation, all medical devices should be inspected. Usually, un-magnified visual inspection under good lighting conditions is sufficient. Inspection of functionality as well as inspection of any potential damage should be performed. Cutting edges should be checked for sharpness and damage. This inspection guide complements the instructions given in the surgical technique brochure, the instructions for use leaflet, the Swemac re-processing instructions and, if applicable, the assembly/disassembly instructions for multi-component instruments. All instructions are available electronically and can be downloaded from the Swemac resource library on http://download.swemac.com/ Hard copies can be provided upon request within 7 days.

Scope This inspection guide provides information about the care and inspection of reusable surgical instruments manufactured by Swemac Innovation AB.

Symbols on the product label (ISO 15223-1)

Non-sterile Packaged devices marked as being non-sterile are supplied in a non-sterile condition and must be disinfected and sterilised before use.

Do not reuse The device is for single use only. A device marked as single use may be re-sterilised, if it has not been used in a surgical procedure and has not been in contact with blood, bone, tissue, or other body fluids in any way (e.g. screws in a screw bank in the tray). This is also applicable to some implants (in odd cases) in sterile packaging with a broken sterile barrier, e.g. if a wrong size was selected and identified before the application so that the implant was not exposed to any of the human substances mentioned above.

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Do not re-sterilize Single-use devices that are not allowed to be re-sterilised due to product characteristics. These devices must be discarded after use or when the sterile barrier is broken.

Guidelines how to check proper functionality of the medical devices Inspection Swemac does not specify the maximum number of uses appropriate for re-usable surgical instruments. The useful life of these devices depends on many factors such as the; method and length of each use, quality and density of bone, type of surgery, fracture complexity and handling between uses. Careful inspection and functional testing of the device before use is necessary and the best method of determining the end of serviceable life for the device. The following guidelines should be applied to all Swemac re-usable instruments. Devices should be examined for damage, including but not limited to; wear, cracks, corrosion, discoloration, excessive scratches, dents, flaking or breakage to ensure safety and performance of the medical devices. Multi-component instruments should be assembled for functional testing. Proper function, including but not limited to, sharpness of cutting tools, drill, reamers, moveable features such as handles, ratcheting, couplings and mating devices needs to be ensured. Improperly functioning devices with defect locking features, movable parts, unrecognisable markings or un-readable measuring scales should be discarded in addition to damaged or worn devices. Ensure that instruments that are to be impacted are not notched to the extent that they malfunction or that burrs have been produced that could damage tissues or surgical gloves. The failure modes may be caused by end of life of the product, improper use or improper handling.

Inspection of re-usable driver tips ... 3 Inspection of re-usable couplings... 5 Inspection of re-usable drills ... 7 Inspection of Targeting Guides... 10 Inspection of Trials ... 11 Inspection of measuring scales and laser markings ... 13 Inspection of Impactors ... 15 Inspection of instrument surface ... 16 Inspection of Awl or instrument with sharp edge ... 17

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Inspection of re-usable driver tips Description and function Re-usable driver tips.

Potential failure modes Defective drill tip or coupling end. Blunt, rounded, twisted, dented tips. Worn down hex tip, scratches, corrosion or damaged coupling.

Preventive maintenance Functional examination, testing and careful visual inspection before every use. In case of damage or failure the instrument must be replaced and shall not to be used.

Worn-out driver tip

Figure 1. Round edges on the Hex tip will prevent the device to function as intended.

Figure 2-3. Round edges on the Hex tip will prevent the device to function as intended.

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Figure 4-6. Twisted tip will prevent the device to function as intended.

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Inspection of re-usable couplings Description and function Re-usable couplings.

Potential failure modes Defective coupling end. Blunt, rounded, dented tip. Worn down Hex tip, scratches, corrosion or damaged couplings.

Preventive maintenance Functional examination, testing and careful visual inspection before every use. In case of damage or failure the instrument must be replaced and shall not to be used.

Worn-out couplings

Figure 7-9. Worn Hex tip and coupling interfaces will prevent the device to function as intended.

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Figure 10-11. Worn coupling interface, corrosion and blunt edges will prevent the device to function as intended.

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Inspection of re-usable drills Description and function Re-usable drills and reamers.

Potential failure modes Blunt, damaged, dented or dull cutting flutes. Blunt, damaged or cracked tip. Scratches or ware markings on the drill. Defective coupling end.

Preventive maintenance Functional examination, control of sharpness and careful visual inspection before every use. In case of damage or failure the instrument must be replaced and shall not to be used.

Drill worn out or damaged

Figure 12-15. Damaged cutting edges will prevent the device to function as intended.

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Figure 16-17. Damaged and worn cutting flutes will reduce the function of the device or prevent the device to function as intended.

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Figure 18. Damaged surface will reduce the function of the device or prevent the device to function as intended.

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Inspection of Targeting Guides Description and function Re-usable Targeting Guides.

Potential failure modes Defective guide. Damages, cracks, dents, marks or scratches created by hitting the guide, or damages created by threads. Breakage due to usage of the guide as re-positioning tool.

Preventive maintenance Handle with care. Do not hit targeting devices, do no use the targeting devices as re-positioning tools. Functional examination, testing and careful visual inspection before every use. In case of damage or failure the instrument must be replaced and shall not to be used.

Damaged or worn-out Targeting Guide

Figure 19-22. Damaged and worn devices will no longer function as intended.

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Inspection of Trials Description and function Re-usable Trials.

Potential failure modes Defective trial. Damaged surface, cracks, breakage, dents, marks or scratches.

Preventive maintenance Handle with care. Do not hit on the trials. Functional examination, testing and careful visual inspection before every use. In case of damage or failure the Trial must be replaced and shall not to be used.

Damaged Trials

Figure 23-26. Damaged or worn surfaces and cracks will prevent the device to function as intended.

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Figure 27. Damaged or worn surfaces and cracks will prevent the device to function as intended.

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Inspection of measuring scales and laser markings Description and function Re-usable instruments with measuring scales or laser marking.

Potential failure modes Measuring scale damaged. Laser marking worn off. Scale or laser marking not visible under normal conditions. Cracks, breakage, dents, marks, scratches or corrosion.

Preventive maintenance Functional examination, testing and careful visual inspection before every use. In case of damage or failure the instrument must be replaced and shall not to be used.

Worn-out measuring scales

Figure 28. Reduced readability of the laser marking will prevent the device to function as intended.

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Worn-out laser marking

Figure 29. Reduced readability of the laser marking will prevent the device to function as intended or result in loss of traceability.

Correct measuring scale Scale should be easy to read under normal conditions.

Figure 30. Clear marking and good readability of a measuring device.

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Inspection of Impactors Description and function Re-usable Impactor.

Potential failure modes Defective Impactor. Damages, scratches, cracks, dents, markings or breakage.

Preventive maintenance Functional examination, testing and careful visual inspection before every use. In case of damage or failure the instrument must be replaced and shall not to be used.

Damaged Impactor

Figure 31. Damaged surfaces and scratches can harm the implants when impacted and prevent the device to function as intended. .

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Inspection of instrument surface Description and function All surfaces should be smooth.

Potential failure modes Scratches, burrs, cracks or cuts could potential damage surgical gloves.

Preventive maintenance Functional examination, testing and careful visual inspection before every use. In case of damage or failure the instrument must be replaced and shall not to be used.

Damaged surface

Figure 32. Damaged surfaces and scratches could potential damage surgical gloves.

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Inspection of Awl or instrument with sharp edge Description and function Re-usable Awl.

Potential failure modes Defective Awl. Damaged, bent or broken tip. Scratches, dents or markings could potential damage surgical gloves.

Preventive maintenance Functional examination, testing and careful visual inspection before every use. In case of damage or failure the instrument must be replaced and shall not to be used.

Awl tip damaged

Figure 33. Damaged tip will prevent the device to function as intended.

Correct Awl tip

Figure 34. Correct representation of the Awl. Tip is as intended.

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Swemac Innovation AB Cobolgatan 1 SE-583 35 Linköping, Sweden Phone: +46 13374030 E-mail: [email protected] http://www.swemac.com

2862 ©2023 Swemac Innovation AB All rights reserved Swemac Inspection Instructions_EN_20230320 Available at http://download.swemac.com

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