H3, h6: it was reported that a polarcup reducer part for impactor was found with gouges.As this was noticed upon field inspection, there was not patient involvement.The complaint device, used in treatment, was returned for investigation.The reported issue could be confirmed upon visual inspection, the device was found with dents and gouges.A review of the batch record revealed no deviations from the standard manufacturing process that could have contributed to the reported issue.A review of the complaint history revealed additional complaints for the batch in question.However, this is a known failure mode and the root cause is attributed to wear and tear of the device.A review of the risk management documentation verifies the failure mode and severity of the reported issue.Review of past corrective actions was performed.No further escalation is required.There are no indications that this failure is related to any manufacturing issues.The root cause is attributed to wear and tear.The relationship between the reported event and the device was confirmed.The need for corrective action is not indicated.Nevertheless, smith + nephew will continue to monitor this version of the device for similar issues internal complaint reference: (b)(4).
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