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 device was returned and evaluated confirming the complaint.It was discovered that the unit has rotational and lateral movement, however residue buildup is present and internal parts worn.General maintenance and cleaning is required.Root cause - based on evaluation by integra service and repair, the root cause is most likely the need for routine preventive maintenance due to normal wear.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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