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.The lock had rotational and lateral movement.Unit received with the lock having rotational and lateral movement and a residue buildup was present.New components were added to replace worn internal parts, and general maintenance and cleaning performed.Root cause - complaint confirmed via inspection of the unit as the lock had rotational and lateral movement.Unit required preventive maintenance and replacement of worn 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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