The mayfield 2000 skull clamp (a2000) 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 clamp does have some slight movement in the hex bushing while in the locked position, but it passed all specific functional testing.The clamp had pressure applied three times onto the test block and repairs team noted that it did not have any findings about it not releasing.All internal components were replaced with new parts due to wear, and general cleaning and maintenance were performed.Root cause analysis - the complaint is not confirmed.The unit passed all specific functional testing.No further investigation is required based on the acceptability of risk and no adverse trends were identified.This will be monitored and trended going forward.At present, we consider this complaint to be closed.
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