The mayfield skull clamp 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.Unit received with the mayfield 2 lock has up and down movement and the teeth are grinding when rotated.All worn components have been replaced with new parts along with general maintenance and cleaning performed.Root cause - based on the evaluation by integra service and repair, the root cause is most likely excessive wear and tear from rough and/or high volume use.No further investigation 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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