The mayfield infinity skull clamp (a1114) was returned for evaluation: device history record (dhr): the dhr was reviewed and shows no abnormalities related to the reported failure.The investigation of the returned device showed that the reported complaint was confirmed from the evaluation.The lock was sticking, the unit had rotational and lateral movement and a residue buildup was present.The unit needs repair, pm, replacement of worn parts and cleaning.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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