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.On inspection of the unit, it was noted that the swivel lock had rotational and lateral movement, however, a residue buildup was present.New components added in order to replace worn internal parts, and general maintenance and cleaning performed.Root cause - unit received in used condition with visible residue buildup and worn internal parts.Root cause determined to be environmental damage and excessive use.Applicable parts replaced and cleaning performed.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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