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: unit received with the lock having both rotational and lateral movement and a residue buildup is present.Upon disassembly repair noted the index knob and the lock will need new components added to replace worn internal parts; unit was machined to have heli-coils added to large starburst threads.Root cause analysis: the reported complaint was confirmed.Evaluation showed that the lock had movement and a residue buildup is present.Unit was machined to have heli-coils added to large starburst threads.The unit needs repair, and replacement of worn and damaged parts.General maintenance and cleaning required.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.
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