The mayfield triad skull clamp (a1108) 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 lock needed new components added to replace worn internal parts.The unit was machined to have heli-coils added to the large starburst threads, new components added to replace worn internal parts, general maintenance and cleaning performed.Root cause: complaint confirmed via inspection of the unit.The lock had movement and the index knob and lock needed new components added to replace worn internal parts.Unit required preventive maintenance and replacement of worn parts as a result of routine wear and tear.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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This report is 1 of 2 linked to mfg report number (b)(4): a facility reported that the mayfield triad skull clamps (a1108) are very difficult to close, the ratchet is not smooth, and it takes a large amount of force to get the clamp to ratchet.Also, the plunder sticks and is difficult to release.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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