The mayfield triad skull clamp (a1108) was returned for evaluation: failure analysis - the investigation of the returned device showed that the reported complaint was confirmed from the evaluation.The unit was unable to be tightened down all the way.The ratchet extension was from our loaner a1108p-18p.The ratchet extension was sticking on the plunger stud and the lock was loose.The slippage could not be duplicated.Further investigation by quality engineering confirms the findings of the service & repair team's evaluation that ratchet extension was sticking, and the lock was loose.Root cause -complaint confirmed via inspection of the unit.The unit was unable to be tightened down all the way.The ratchet extension was from a loaner unit a1108p-18p.The ratchet extension was sticking on the plunger stud and the lock was loose, requiring replacement of worn internal parts from routine use and wear.This unit is beyond integra¿s 7 years recommended life cycle (manufactured 2010).The reported slippage could not be duplicated; however, improper or suboptimal placement of the skull clamp can contribute to slippage of the skull clamp.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.
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A facility reported that during a posterior fossa tumor resection procedure, the mayfield triad skull clamp (a1108) would not tighten down all the way and stay secure.It slipped while on patient, causing a cut/injury on the right side of the patient's head, approximately "1 1/2 to 2" long.There was a delay of 30 to 45 minutes as the surgeon stapled the wound closed.
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