DALL MILES VIT 2.0MM CABLE

Additional Manufacturer Narrative

IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED.

Description of Event or Problem

REVISION PROCEDURE OF PROXIMAL FEMUR GMRS. MULTIPLE PREVIOUS REVISIONS: CABLES IMPLANTED DURING PROCEDURE (B)(6) 2023. NO DETAILS AVAILABLE OF PROCEDURES PRIOR TO THIS DATE. DALL MILES CABLE HAD SNAPPED AND FRAYED IN THE PATIENT. CABLES AND CABLE GRIP REMOVED AND FRAYED METAL REMOVED UNDER X RAY GUIDANCE. NO NEW IMPLANTS WERE PUT IN. ALL OF THE ITEMS ARE STILL IN PATIENT EXCEPT FOR THE CABLES AND CABLE GRIP WHICH WERE REMOVED DURING THIS EVENT.