Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h10.The mayfield skull clamp (a1059) 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 a1059 skull clamp revealed that its locking mechanism has play and needed to be adjusted.Some small parts need to be replaced along with the index knob as the rolling balls are stuck inside and unable to move.The unit also needed to be checked.To resolve all issues, the required small parts were exchanged with the index knob and the closure was reset.The function of the terminal has been checked.Root cause - complaint confirmed via inspection of the unit.There was play in the locking mechanism of the returned skull clamp and it required replacement of worn components due to routine use and wear.No further investigation is required based on the acceptability of risk and no adverse trends were identified.This will be monitored and trended going forward.At present, we consider this complaint to be closed.
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