The mayfield skull clamp (a2000) 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.On inspection, it was noted that the hex bushing was worn, and the lock still moves after it is locked down.Worn components replaced with new parts, and general maintenance and cleaning has been performed.Root cause - unit was received in used condition with visible wear to internal components.Root cause is likely due to excessive use over time.No further investigation is required based on risk acceptability and no manufacturing defects were discovered.This will be monitored and trended going forward.
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