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 lock had rotational and lateral movement and a residue buildup was present.Also, the index knob was loose.To resolve all issues, new components were added to replace worn internal parts, and general cleaning and maintenance were performed.Root cause - the complaint is confirmed via inspection of the unit.The unit required replacement of worn internal parts due to 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.At present, we consider this complaint to be closed.
|