It was reported that during use, outside the patient, when removing the shutter with the loop from the set meniscus mender ii disposable it breaks at the height of the joint of the needle and head.It is unknown if a backup device was available and if occurred a surgical delay.Patient injuries were not reported.
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The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.Insufficient product identification information was provided, and thus, a manufacturing record review could not be conducted.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
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