The mayfield skull clamp was returned for evaluation: failure analysis - the investigation of the skull clamp revealed that the locking mechanism shows minimal axial movement, which must be overhauled.The torque of the locking is according to manufacturer¿s specification.A pretest was performed.Some worn off small parts must be replaced., and afterwards the function must be checked.To resolve all issues, the locking mechanism has been overhauled.The small parts have been replaced, and the function test has been performed.Root cause - complaint confirmed via inspection of the unit.There was movement present in the locking mechanism of the returned unit and it required repair and 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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