SMITH & NEPHEW, INC. GII ARTICULAR INSERTER/EXTRACT; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Model Number 71440194 |
Device Problem
Material Twisted/Bent (2981)
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Patient Problem
No Patient Involvement (2645)
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Event Date 09/09/2020 |
Event Type
malfunction
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Event Description
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It was reported that the tip of the gii articular inserter/extract was found to be bent, it was pulled out of service.No case related, therefore no patient involved.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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Manufacturer Narrative
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Results of investigation: the device, intended use in treatment, was returned for evaluation.A visual inspection confirmed the gii articular inserter/extract is bent.The device shows significant signs of wear/usage.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A review of complaint history for the listed part revealed no prior complaints for the listed batch.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.This is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.
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