The reported event could be confirmed.The device inspection revealed the following: the visual inspection of the screws and plate returned showed that the plate was indeed broken in two parts at the level of the 4th screw hole and that the returned locking screws are intact and therefore concomitant.The identification of the device wrist fusion plate straight variax 2 wrist fusion 120mm is confirmed based on the lot number and the catalog number marked.Signs of a fatigue fracture are visible with the microscopic analysis of the broken area, such as a fracture surface that is shiny and abraded.This is a result of the fragments (opposing bridges of the plate) rubbing against each for an extended period of time, before completely breaking due to fatigue and overloading.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 investigation, the root cause was attributed to a patient related issue.The failure was probably caused by repeated overloading of the plate.If any additional information is provided, the investigation will be reassessed.
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