SMITH & NEPHEW, INC. PWR ADAPTER-SMALL AO MALE; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
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Catalog Number 71119022 |
Device Problem
Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/16/2019 |
Event Type
malfunction
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Event Description
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It was reported that during surgery the adaptor became jammed.No injury nor delay was reported.No backup device could be made available in a timely manner, therefore an adaptor from stryker was decided to be used on the drill to finish the surgery.
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Manufacturer Narrative
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The device, used in treatment, was returned for evaluation.A functional evaluation was performed and confirms the power adapter-small ao male is working properly, not jamming, and mates up with quick coupling handle.A visual inspection was performed and confirmed the power adapter-small ao male is discolored and has gouges on the device.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
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