The mayfield skull clamp (a1059) was returned for evaluation: device history record (dhr) - the dhr was reviewed, and no anomalies related to the reported failure was observed.Failure analysis - the investigation of the returned device found no device deficiencies that would have contributed to the reported complaint which states"during tightening, the piston did not work, had too high of compression and led to fracture of the forehead".Unrelated to the complaint event, service and repair found that there was movement in the locking mechanism and the plunger was bent.The unit has been scrapped.Root cause - probable root cause is routine wear and rough handling of the unit.No corrective action is required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.At present, we consider this complaint to be closed.
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