It was reported that during procedure it was found that the locking tab snapped off.No injuries or surgical delays reported.The device, used in treatment, was not returned for investigation.A functional evaluation of the product could therefore not be performed.However, a picture of the broken device was provided.Based on this picture, it is clearly visible, that one of the flaps broke.The flap breakage of this device is a known problem.Previous investigations demonstrated that the trial femoral head may disconnect from the stem taper intra-operatively and flaps might break off.In combination with our continuous effort to improve our products, evaluations aimed at optimizing this instrument have been initiated.The performance of the device is nonetheless within the risks, which are anticipated in the risk management documentation of the product, both in occurrence and severity.The continued performance of the device shall be monitored through standard pms review processes.The reported faillure mode of a flap breakage can be confirmed, the root cause is attributed to an insufficient design specification.S+n will continue to monitor this device for similar issues.The complaint will be reopened, should the device be returned or should further information arrive.
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