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.Unit was machined to have heli-coils added to the large starburst threads, and the plunger cap was replaced due to being received with a competitor¿s cap.Root cause analysis: complaint was confirmed via inspection of the unit.The index knob was not locking properly.The index knob and lock required new components added to replace worn internal parts from routine use and wear.No further investigation is required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.
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