Mayfield composite series skull clamp (a3059) was returned for evaluation: device history record (dhr) - the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis - investigation of the returned unit showed that the unit had up and down movement in the lock, and there was also movement while in the locked position.To resolve the issues, the disk ratchet and retainer were replaced due to wear, and all worn components were replaced with new parts.Additionally, general maintenance and cleaning were performed.Root cause - complaint confirmed via inspection of the unit.The unit required replacement of worn components due to routine use and wear.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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A facility reported that when locked, there is 'play' in the mayfield composite series skull clamp (a3059) system.No information has been provided on patient involvement, injury, or surgical delay.
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