The mayfield modified 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 - the investigation of the returned device showed that the reported complaint was confirmed from the evaluation.The unit was received with the lock having both rotational and lateral movement and a residue buildup is present.Upon disassembly, repair noted the index knob and the lock needed new components to replace worn internal parts.The unit was machined to have heli-coils added to the large starburst threads, and the helicoil in the ratchet extension was replaced due to it coming out.New components have been added to replace worn internal parts, along with general maintenance and cleaning performed.Root cause - complaint confirmed via inspection of the unit.The heli-coil was coming out of the ratchet extension and needed to be replaced.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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A facility reported that the threads where skull bolt screws in on the mayfield modified skull clamps (a1059) were protruding.It is unknown if there was patient involvement; however, no patient injury or surgical delay has been reported.After the device was returned by the customer, evaluation showed that it had movement.
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