STREAMLINE TL SPINAL FIXATION SYSTEM

Description of Event or Problem

THE MANUFACTURER WAS MADE AWARE OF A PRODUCT COMPLAINT ON 06/23/2026. IT WAS REPORTED THAT THE DISTAL TIP OF A SYSTEM SCREWDRIVER WAS BROKEN DURING A T12-S1 REVISION TRANSFORAMINAL LUMBAR INTERBODY FUSION WITH A L2/3 PEDICLE SUBTRACTION OSTEOTOMY PROCEDURE. THE COMPLAINANT CONFIRMED THERE WERE NO KNOWN PATIENT COMPLICATIONS OR DELAYS IN PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING AN ALTERNATE FINAL DRIVER. A RETURN AUTHORIZATION NUMBER WAS ISSUED FOR THE RETURN OF THE DAMAGED FINAL DRIVER, WHICH WAS RECEIVED BY THE MANUFACTURER ON 07/14/2026.

Additional Manufacturer Narrative

A VISUAL ASSESSMENT OF THE RETURNED SYSTEM SCREWDRIVER SHOWED AN INSTRUMENT WITH REPEATED USE, AS IDENTIFIED BY SURFACE LEVEL SCRATCHES. THE DISTAL TIP OF THE INSTRUMENT WAS FRACTURED AND NOT PRESENT AS REPORTED. A FUNCTIONALITY ASSESSMENT WAS NOT PERFORMED DUE TO THE DAMAGED CONDITION OF THE RETURNED DRIVER.A DHR REVIEW WAS PERFORMED FOR THE LOT 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 08/14/2017, RESULTING IN A LIFESPAN OF APPROXIMATELY NINE YEARS.IT WAS REPORTED THAT A RATCHETING T-HANDLE WAS ATTACHED TO THE FINAL DRIVER DURING FINAL SET SCREW LOCKING INSTEAD OF THE TORQUE-LIMITING HANDLE. PER THE SYSTEM SURGICAL TECHNIQUE GUIDE, THE FINAL DRIVER MUST BE USED IN COMBINATION WITH TORQUE-LIMITING HANDLE TO COMPLETE FINAL SET SCREW LOCKING. THE ROOT CAUSE OF THE BROKEN DISTAL TIP WAS DETERMINED TO BE EXCESSIVE ROTATIONAL FORCE DUE TO THE INCORRECT HANDLE BEING UTILIZED DURING FINAL SET SCREW LOCKING.THERE HAVE BEEN SEVEN OTHER COMPLAINTS OF SIMILAR NATURE IN THE PAST 12 MONTHS. THE MANUFACTURER WILL CONTINUE TO MONITOR FOR REPORTS OF MALFUNCTIONED SYSTEM SCREWDRIVERS AND PERFORM COMPLAINT INVESTIGATIONS AS APPROPRIATE.