The reported event could be confirmed, although the device was not returned for evaluation; photographs and an x-ray image were provided as part of the investigation.A review of the provided picture and post-operative x-ray confirmed the nail was completely broken from the webs of proximal hole.Based on the provided x-ray, a medical opinion was sought from the medical expert, but no conclusive statement or opinion could be made due to insufficient information.¿it is very likely, that non-union led to permanent load on the nail and then breakage occurred.Subtrochanteric fracture with quite a high rate of expected non-union.Difficult to say without further x-rays.¿ additional information was provided by the customer where the patient¿s bone quality was deemed osteoporotic and malunion of bone also occurred.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.Through the provided information, the exact root cause could not be determined.However, one of the probable root causes would be, but not limited to: non-union which led to permanent load on the nail and then breakage occurred and patient factor (osteoporotic bone).A review of the labeling did not indicate any abnormalities.If the device is returned or if any additional information is provided, the investigation will be reassessed.
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