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 showed that the unit was received with the lock having rotational and lateral movement and a residue buildup was present.New components were added to replace the worn internal parts, and general maintenance and cleaning was performed.Root cause analysis: complaint confirmed via inspection of the unit.The unit had a loose lock due to residue and worn parts inside the lock.Potential root cause is normal wear and tear.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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