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 swivel ratchet does not lock when position roll over, torque screw cannot be verified.The unit required replacement of components; therefore, repair was completed to meet manufacturer's specifications.Root cause : complaint confirmed via inspection of the unit.Probable root cause is 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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