The mayfield skull clamp 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 showed that all specific functional testing requirements, except for the lock having rotational movement when the unit is not under pressure.However, this would not have caused a slippage as when the unit is properly positioned and put under pressure, the unit would not have slipped.General maintenance and cleaning has been performed.Root cause - evaluation found no device deficiencies that would have contributed to the reported complaint.Service and repair found when the unit is properly positioned and put under pressure the unit would hold its position and not slip.Probable root cause for the reported complaint is improper positioning 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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