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The reported event could be confirmed since the device was returned for evaluation and matches the alleged failure.Four screws were received for evaluation; however, one screw had fractured at the distal end, and the broken fragment was not returned for analysis.Examination of the remaining screws revealed severe deformation of the initial locking threads, which is prominent and visible on the screw holes on the plate.The broken surface characteristics suggest a combined fatigue and brittle failure mechanism.This assessment is based on the relatively flat fracture surface indicative of progressive crack propagation, along with shiny areas observed at the fracture edges and corners, which are consistent with the final rapid fracture and separation of the component.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.No product related issue could be detected during the performed investigation of the returned device.Regarding the root cause of the implant failure no conclusive statement can be provided, because key clinical information (e.G.X-rays in different planes, clinical status, patient activity, assessment of the treating physician or operation reports) is missing.The root causes in such cases are often complex and multifactorial and cannot be determined scientifically without this decisive evidence.Due to these limitations, we are unable in such cases to provide statements about the patient, the procedure and/or the device in relation to cause of the failure.If any additional information is provided, the investigation will be reassessed.
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