The mayfield skull clamp (a3059) 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 18-pound infinity pediatric torque knob, with the mayfield 2 lock having up and down movement and the teeth were grinding when rotated.All worn components were replaced with new parts.General maintenance and cleaning also performed.Root cause - complaint confirmed via inspection of the item.The mayfield 2 lock had up and down movement and the teeth were grinding when rotated.Unit required preventive maintenance and replacement of worn parts as a result of routine wear and tear.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.
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