This supplemental report is being submitted to provide the results of the legal manufacturer¿s investigation and the results of the device history records (dhr) review.The olympus service center evaluated the returned device and identified the following: part was not returned in original packaging, the device was returned in closed specimen cup with solution.The device was noted for the nitinol wire and fluoroplastic anchor being in tacked.The loop on the nitinol wire was present but the wire shaft is bent.The wire shaft should be straight leading into the fluoroplastic.There is no color difference in material, the nitinol wire is grey in color and the fluoroplastic is white in color.The reported failure could have occurred when connecting the hook around the bone (incus) and securing the fluoroplastic end to the open window.The nitinol wire could have bent in the process.The dhr for this device were reviewed and all records indicated the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.A definitive root cause was not identified.Based on the available information, the legal manufacturer determined the probable cause of the failure is likely due to transportation or customer use.Per instructions for use: the shape-memory properties of the nitinol are designed to aid the surgeon in the crimping of the wire loops around the incus or malleus.In most cases, further crimping will not be necessary, however, the surgeon should always check the wire loops to determine if additional manual adjustment (tightening or loosening) of the crimp should be made.Olympus will continue to monitor field performance for this device.
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