The mayfield modified skull clamp (a1059) was returned for evaluation: device history record (dhr) - the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis - investigation of the returned unit showed that the lock had rotational and lateral movement and a residue buildup was present.New components were added to replace worn internal parts, and general maintenance and cleaning were performed.Root cause -complaint confirmed via inspection of the unit.There was movement present in the lock and the unit required replacement of worn components due to routine use and wear.No further investigation is required based on the acceptability of risk and no adverse trends were identified.This will be monitored and trended going forward.At present, we consider this complaint to be closed.
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