The mayfield skull clamp (a1059) was returned for evaluation: device history record (dhr) - the dhr was reviewed, and no anomalies related to the reported failure was observed.Failure analysis - inspection of the returned unit showed that the locking mechanism had some movement.As a result, the index knob was replaced with all required small parts to overhaul the swivel lock assembly.After cleaning and reassembling the skull clamp, the base casting was marked and the unit was function tested.Root cause - the investigation of the returned device found no device deficiencies that would have contributed to the reported complaint.However, there was movement in the locking mechanism and the unit required replacement of worn components from routine wear.Additionally, probable root cause of the reported slippage is improper or suboptimal 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.At present, we consider this complaint to be closed.
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