The reported event could only partially be confirmed, since the device was returned, but no x-rays were provided.More detailed information about the complaint event (x-rays, operative surgery.) must be available in order to determine the root cause of the complaint event.The device inspection revealed the following: the product was returned and shows severe signs of wear (multiple scratches are noticed).Moreover, the implant is partially cut in two.Unfortunately, the analysis of the returned device alone is not sufficient to allow us to draw conclusions on this case.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the investigation report will be updated.
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