The mayfield skull clamp (a1117) 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 received skull clamp had missing and broken parts that required replacement.Unit had a cross cut piston long replaced due to not being received with the unit.The transfer board knobs were replaced due to not being received with the unit.The keepers on the skull clamp were replaced due to showing heavy wear.The traded engagement shaft in the blue case was replaced due to having a broken tab.General maintenance and cleaning performed -unit was cleaned as a pm.Root cause - the complaint is confirmed via inspection of the unit.Probable root cause is rough handling or mishandling of the unit.Additionally, improper or suboptimal positioning of the skull clamp on the patient can contribute to slippage of the patient's head.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.
|