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 normal wear over time.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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