The mayfield skull clamp (a3059) was returned for evaluation: device history record (dhr) - the dhr was reviewed, and no anomalies related to the reported failure was observed.Failure analysis - the investigation of the returned device found no device deficiencies that would have contributed to the reported complaint.However, the unit has slight rotational movement in the lock, but when the unit is properly positioned and put under pressure, it would not move.Root cause - the complaint was not confirmed as repairs could not duplicate loss of pressure.However, evaluation found slight movement in the lock and required replacement of worn components due to routine use and wear.Additionally improper or suboptimal placement of the skull clamp can contribute to loss of pressure or movement of the patient's head.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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