A physician reported that the mayfield composite series skull clamp (a3059) was loose and seemed to move.Additionally, the locking mechanism seems to stick.No information has been provided on patient involvement, injury, or surgical delay.
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The 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 lock was sticking and the teeth on the starburst were worn.To resolve the issue, the base casting was replaced due to having worn starburst teeth, and the disk ratchet and retainer were replaced due to the replacement of the base casting.All worn components were replaced with new parts, and general maintenance and cleaning were performed.Root cause - the complaint is confirmed via inspection of the unit.The unit required replacement of worn components and replacement of the base casting from routine use and wear of the clamp.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.At present, we consider this complaint to be closed.
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