It was reported that on literature review, "comparative analysis of early application of peroneus longus tendon and hamstring tendon for anterior cruciate ligament reconstruction", 10 patients developed deep vein thrombosis after surgery with an endobutton.No further information is available.
|
H3, h6: 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.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A review of risk management files found that the reported failure was documented appropriately.A complaint history review concluded this was a repeat issue.Attempts to obtain medical documents were unsuccessful and thus a thorough medical investigation was not performed.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.
|