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 - complaint confirmed via inspection of the unit.The lock had rotational and lateral movement, requiring replacement of worn internal parts.Unit received with the lock having rotational and lateral movement and a residue buildup was present.Upon disassembly, repair noted the index knob and lock will need new components added to replace worn internal parts.Unit was machined to have helicoils added to the large starburst threads.General maintenance and cleaning performed, new components added to replace worn internal parts.And helicoils added to large starburst threads.Root cause - complaint confirmed via inspection of the unit.The lock had rotational and lateral movement, the index knob and lock required replacement of worn internal parts.Probable root cause is 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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