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: unit received with the lock having rotational and lateral movement and a residue buildup was present.General maintenance and cleaning required at this time.New components were added to replace worn internal parts.Root cause analysis: unit received with the lock having rotational and lateral movement.Unit required preventive maintenance and replacement of worn internal parts as a result of normal wear and tear.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
|