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: the investigation of the returned device showed that the reported complaint was confirmed from the evaluation.Unit received with the lock having both rotational and lateral movement and a residue buildup was present.Upon disassembly, it was noted that the index knob and the lock needed new components added to replace worn internal parts.To resolve all issues, the unit was machined to have heli-coils added to the large starburst threads, new components were added to replace worn internal parts, and general maintenance and cleaning was performed.Root cause: complaint confirmed via inspection of the unit.Unit received with movement in the lock.The index knob and lock required replacement of worn internal parts due to routine use and wear.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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