Correction: method code.The reported event could not be confirmed since the involved devices were not returned for evaluation and no other evidences were provided.The root cause could not be determined specifically.The medical opinion of a medical expert states that "the fact that the patient developed the ulnar neuropathy four days after surgery, makes it plausible that it was caused by direct pressure on the ulnar nerve by the internal-rotation orthosis, that the patient was wearing after surgery".However, more information is required to determine an exact root cause.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 the device is returned or if any additional information is provided, the investigation will be reassessed.
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