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 rotational and lateral movement in the lock, requiring replacement of worn internal parts.Root cause analysis: complaint confirmed via inspection of the unit.Unit received with rotational and lateral movement in the lock, requiring 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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