The mayfield infinity xr2 skull clamp (a2114) 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.The device passed 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.When the unit is properly positioned and put under pressure the unit would not have slipped.No repairs are needed at this time.Root cause - evaluation found no device deficiencies that would have contributed to the reported complaint.Repairs team could not duplicate slippage.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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