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 - the investigation of the returned device found no device deficiencies that would have contributed to the reported complaint.When the unit is properly positioned and put under pressure it does not move, and "slippage" could not be duplicated in the 80lb torque knob.Unrelated to the complaint issue, the lock has rotational and lateral movement and a residue buildup.As a result, new components were added to replace worn internal parts along with general cleaning and maintenance performed.Root cause - evaluation found no device deficiencies that would have contributed to the reported complaint.Probable root cause is improper or suboptimal positioning of the skull clamp on the patient.No further investigation 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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