The reported event that foot arch hoffmann lrf 180mm was alleged of 'instrument breakage identified out of surgery' could be confirmed, based on provided picture.Based on investigation, the root cause was attributed to be patient related.The failure was caused by overlaoding of the device.It was reported that patient is overweighted, has no sensation in the foot as diabetic and may not be weight bearing properly (putting weight on the more medial aspect of his foot).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 the device is returned or if any additional information is provided, the investigation will be reassessed.Device was not return.
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