Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h10 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 - investigation of the returned unit showed that the index knob was loose, and the device required replacement of parts.The repair has been completed and the unit meets manufacturer's specifications.Root cause - the complaint is confirmed via inspection of the unit.Probable root cause is routine use and wear of the unit.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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