STREAMLINE TL SPINAL FIXATION SYSTEM

Additional Manufacturer Narrative

A VISUAL ASSESSMENT OF THE RETURNED SYSTEM FINAL DRIVER SHOWED AN INSTRUMENT WITH REPEATED USE, AS IDENTIFIED BY SURFACE SCRATCHES AND WORN LASER MARKINGS. THE DISTAL TIP OF THE INSTRUMENT WAS NOT PRESENT AS REPORTED. A FUNCTIONALITY ASSESSMENT WAS NOT PERFORMED DUE TO THE DAMAGED CONDITION OF THE RETURNED DRIVER, WHICH WAS REMOVED FROM DISTRIBUTABLE INVENTORY. A DHR REVIEW WAS PERFORMED FOR LOT # 067339 AND THERE WAS NO MANUFACTURING ANOMALIES IDENTIFIED. THE INSTRUMENT LOT MET ALL REQUIRED SPECIFICATIONS PRIOR TO BEING RELEASED TO DISTRIBUTABLE INVENTORY. THIS LOT HAS BEEN AVAILABLE FOR DISTRIBUTION SINCE (B)(6) 2010, RESULTING IN A LIFESPAN OF 15 YEARS. THE ROOT CAUSE OF THE BROKEN DISTAL TIP COULD NOT BE RELIABLY DETERMINED, HOWEVER, IT MAY BE POSSIBLE FOR THE DISTAL TIP OF THE SCREWDRIVER TO BE BROKEN IF EXCESSIVE ROTATIONAL FORCE WAS APPLIED, OR IF THE SCREWDRIVER WAS SHIFTED OUT OF ALIGNMENT WHILE ENGAGED WITH A SYSTEM IMPLANT SCREW. THERE HAS BEEN ONE OTHER COMPLAINT OF SIMILAR NATURE IN THE PAST 12 MONTHS. THE MANUFACTURER WILL CONTINUE TO MONITOR FOR REPORTS OF MALFUNCTIONED SYSTEM INSTRUMENTS AND PERFORM COMPLAINT INVESTIGATIONS AS APPROPRIATE.

Description of Event or Problem

THE MANUFACTURER WAS MADE AWARE OF A PRODUCT COMPLAINT ON (B)(6) 2025. IT WAS REPORTED THAT THE TIP OF A FINAL DRIVER WAS DAMAGED WHEN REMOVING SCREWS DURING A LUMBAR FUSION PROCEDURE PERFORMED ON (B)(6) 2025. AN ALTERNATIVE INSTRUMENT WAS AVAILABLE TO SUCCESSFULLY COMPLETE THE SURGERY. THERE WAS NO DELAY IN SURGERY AND NO KNOWN PATIENT COMPLICATIONS. A RETURN AUTHORIZATION WAS ISSUED FOR THE RETURN OF THE COMPLAINT DRIVER, WHICH WAS RECEIVED BY THE MANUFACTURER ON (B)(6) 2025.