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 showed that the lock had rotational and lateral movement and a residue buildup was present.Unit was also received without the 80-pound torque knob.Unit was sent to quality engineering for further evaluation since a patient injury was reported, and further investigation by quality engineering confirms the findings of service and repair.Root cause analysis: evaluation was unable to confirm if the clamp had slipped or lost pressure.No issues were observed apart from minor movement in the lock from routine use and wear.Probable root cause is improper or suboptimal placement of the skull clamp on the patient.No further investigation is required based on the acceptability of risk and no adverse trends were identified.This will be monitored and trended going forward.
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