The mayfield composite series skull clamp (a3059) was returned for evaluation: device history record (dhr): the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis - the investigation of the returned device found that the reported issue could not be duplicated.The clamp does have up and down movement in the lock, and the teeth were grinding while in the unlocked position.However, despite the movement, when the clamp is properly positioned and put under pressure, it would not have moved.The unit was sent to quality engineering for further investigation, and the findings of the service & repair team have been confirmed as no additional device deficiencies were noted.All worn components were replaced with new parts, and general maintenance and cleaning were performed.Root cause - evaluation found no device deficiencies that would have contributed to the reported complaint.The probable root cause is improper or suboptimal placement of the skull clamp on the patient.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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A facility reported that the pin of the mayfield composite series skull clamp (a3059) did not hold pressure, and as a result, the clamp slipped and cut the patient.There was no delay in surgery reported, and patient outcome has been reported as "doing good.".
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