The 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 - with respect to the returned unit, it has passed all specific functional testing requirements, except for the lock having rotational movement.When the unit is properly positioned and put under pressure it will function properly.General maintenance and cleaning required root cause - evaluation found no device deficiencies that would have contributed to the reported complaint.Repairs could not duplicate slippage.Probable root cause for reported complaint would be improper placement of the skull clamp.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.
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