The mayfield 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 reported complaint was confirmed from the evaluation.The ratchet casting was bent due to misuse and could not be inserted smoothly into the skull clamp base.The received torque screw was not an integra product.There was movement in the lock and the unit required replacement of worn components.To resolve all issues, the internal parts to adjust the unit were replaced according to the manufacturer and the skull clamp's swivel lock assembly was cleaned.After completing the reassembly, the skull clamp was subjected to a successful function test.Root cause: complaint is confirmed via inspection of the unit.Probable root cause of the reported complaint is rough handling of the skull clamp and improper or suboptimal placement of the skull clamp on the patient.No corrective action has been initiated for the same or similar issue.This will be monitored and trended going forward.At present, we consider this complaint to be closed.
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