Correction: d4 serial number.The reported event could be confirmed, since x-rays were provided.On the visual inspection of the device, we can observe that the layer of pyrocarbon is gone on a large third of the surface, but that the graphite below is little damaged.Since data and x-ray and medical report, the opinion of the medical expert was requested and stated as following: this is indeed an interesting case.The screw that was closest to the joint and was already sticking out of the bone at the articular side was left in place unfortunately.That is for sure a user-related issue.Also, the caution was ignored, by that taking a large risk.A surgeon related issue is the obvious root cause for this event.Based on investigation, the root cause was attributed to a user related issue.The event was caused because the product was used against the clear warning in the documentation.A review of the device history for the reported lot did not indicate any abnormalities.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 more information is provided, the case will be reassessed.
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