Please note correction to sections the device was not returned.The reported event could be confirmed, since the broken nail is visible on the received pictures.The picture review revealed the following: the broken nail and a lag screw are visible on one picture.The nail is broken apart at the lag screw hole.The visible wear marks at the lag screw indicate that the devices were implanted for an unknown period of time and that nail did not break during the implantation as initially reported.A device inspection was not possible since the affected device was not returned, therefore no further evaluation is possible.The received pictures were also reviewed by a medical expert with following result: the nail obviously broke after it was some time implanted, since callus has formed at the fracture site in the meantime.The speaks against a breakage during insertion as initially reported.The post-operative breakage of the nail is also visible the x-ray, while another x-ray shows that the nail was replaced with a hip prosthesis.A fragment can be seen at the femoral neck immediately after insertion of the nail.It is not clear if the head fragment was introduced in a strongly rotated position.We also see the massively dislocated lesser trochanter resulting in a lack of medial support.So it's not an easy breakage overall.The patient also has considerable arthrosis in the hip joint.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.More detailed information about the complaint event, like x-rays in different planes, patient data, catalog # lot # and as well as the affected device must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.H3 other text : device disposition is unknown.
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