SMITH & NEPHEW, INC. BOX CHISEL; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Model Number 71440373 |
Device Problems
Failure to Align (2522); Naturally Worn (2988)
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Patient Problem
Insufficient Information (4580)
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Event Date 10/27/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Internal complaint reference case (b)(4).
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Event Description
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It was reported that, a box chisel was knicked and no longer fitting well.It is unknown whether the event happened during surgery and if there was patient involvement.
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Manufacturer Narrative
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H3, h6: the device, intended for use in treatment was returned for evaluation.A visual inspection of the returned device confirmed the stated failure mode.The box chisel shows excessive scratches and dents rendering device inoperative.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.
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