Mayfield composite series skull clamp (a3059) 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 mayfield 2 lock has up and down movement and the teeth are grinding when rotated.The disk ratchet and retainer was replaced due to wear.General maintenance was performed and worn parts were replaced.Root cause - the reported complaint was confirmed from the evaluation.Evaluation showed that the lock has up and down movement and the teeth are grinding when rotated.The disk ratchet and retainer are worn.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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