The reported event could be confirmed, since the device was returned for evaluation and matches the alleged failure mode.Device inspection revealed the following: the received locking screw was found to be broken around the distal region.The tip of the screw had sheared off.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.A review of the labeling did not indicate any abnormalities.Based on the above investigation, the root cause of the failure is patient related (patient factors issue).The surgeon commented that the patient was a smoker and other patient factors had led to delayed union and that¿s why he felt implant had broken.Smoking cigarettes has been shown to have a significant impact on broken bone healing.The labeling also states ¿these devices can break when subjected to the increased loading associated with delayed unions and/or non-unions.Internal fixation devices are load sharing devices which are intended to hold fractured bone surfaces in apposition to facilitate healing.If healing is delayed or does not occur, the appliance may eventually break due to metal fatigue.Loads on the device produced by load bearing and the patient¿s activity level will dictate the longevity of the device.¿.If any additional information is provided, the investigation will be reassessed.
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