A facility reported that during an emergency operation after abdominal positioning and traction on the mayfield modified skull clamp, there was loss of pressure via the clamp, causing it loosen.This resulted in laceration of the patient's head.It is unknown if the event led to increased surgery time.
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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 is confirmed by the evaluation.There was play in the pivot lock and a buildup of debris, some worn internal parts needed to be replaced as it was difficult to close.Also, the index button needed to be replaced and general maintenance and cleaning were required.To resolve all issues, the internal parts were replaced along with the index knob to adjust the unit to manufacturer's specifications and to clean the skull clamp pivot lock assembly.After assembly was completed, the skull clamp was subjected to a successful functional test.Root cause - the complaint is confirmed via inspection of the unit.There was movement in the swivel lock and a buildup of debris, and the unit required cleaning and replacement of worn parts.Probable root cause is routine use and wear and lack of preventive maintenance.No further investigation is 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.
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