SPINE INSTRUMENTS

Additional Manufacturer Narrative

PRELIMINARY INVESTIGATION THE IMAGE SHOWS THREE T20 SCREWDRIVERS WITH FRACTURED TORX TIPS AT APPROXIMATELY A 45° ANGLE, WHICH IS INDICATIVE OF EXCESSIVE TORQUE APPLICATION. ADDITIONALLY, ANOTHER SCREWDRIVER IS VISIBLE WITH THE PEDICLE SCREW STILL ATTACHED. FOR THE PEDICLE SCREWDRIVER, BREAKAGE CAN OCCUR IN CASE OF HIGH INSERTION TORQUE, TYPICALLY RELATED TO LARGE DIAMETER SCREWS (≥7MM), LONG SCREWS (≥60MM), AND/OR HARD BONE (E.G. SACRAL BONE, SCLEROTIC BONE). IN SUCH CASES, BONE TAPPING IS RECOMMENDED IN THE SURGICAL TECHNIQUE. IN THIS CASE SCREW SIZE: D 9X55; D 8X55; D 9X50 TAPPING: YES, UNDERSIZED BONE QUALITY: HARD LEVEL: L5 THE INSTRUMENT SET INCLUDES TWO SCREWDRIVERS AND ANOTHER SCREWDRIVER (REF 03.51.10.0140 OR EQUIVALENT) TO COMPLETE THE SURGERY IN CASE OF BREAKAGE. THE STRENGTH OF THE TIP OF THE SCREWDRIVER IS DETERMINED BY THE DIMENSION OF THE INTERFACE (HEXALOBE T20) AND THE MATERIAL (AISI 420 MOD), WHICH ARE COMPARABLE TO PREDICATE DEVICES. GEOMETRICAL FEATURES ARE DRIVEN BY THE IMPLANT DESIGN AND ARE EQUIVALENT TO SIMILAR PRODUCTS IN THE MARKET. THE MATERIAL IS AMONG THE STRONGEST FOR SUCH APPLICATION IN TERMS OF STRENGTH AND HARDNESS. IT HAS BEEN REPORTED THAT THE SCREWDRIVER FRACTURED DURING INSERTION OF THE D 8 SCREW FOLLOWING FULL-LENGTH TAPPING WITH A SOLID UNDERSIZED D 9 TAP. THE ROOT CAUSE MAY BE RELATED TO HIGH BONE DENSITY COMBINED WITH A MISMATCH IN TRAJECTORY BETWEEN THE SCREW AND THE PATH CREATED BY THE TAP. BATCH REVIEW PERFORMED ON 25 JUNE 2026, LOT: 1952999: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-SEP-2019. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 8 SIMILAR EVENTS HAVE BEEN REPORTED ON THE SAME LOT. LOT: 1550541A: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-NOV-2015. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO SIMILAR EVENTS HAVE BEEN REPORTED ON THE SAME LOT DURING THE PERIOD OF REVIEW. LOT: 2357312: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-JUNE-2024 AND 23-JULY-2024. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, THREE SIMILAR EVENTS HAVE BEEN REPORTED ON THE SAME LOT DURING THE PERIOD OF REVIEW. ROOT CAUSE: WE ARE WAITING FOR THE PIECES.

Description of Event or Problem

REVISION SURGERY OF AN L2D L5 STABILIZATION WAS PERFORMED DUE TO BREAKAGE OF THE LEFT L5 SCREW, 6X55 MM, AND LOOSENING OF BOTH L2 SCREWS (MDR 2026-00591). THE SURGEONS REPLACED THE SCREWS AT L5 AND L2 AND THEN EXTENDED THE CONSTRUCT TO L1. DURING THE PROCEDURE, FOUR SCREWDRIVERS EXPERIENCED TIP BREAKAGE. THE SEQUENCE OF EVENTS WAS REPORTED AS FOLLOWS: THE BROKEN LEFT L5 SCREW WAS REMOVED USING A CORING INSTRUMENT FROM ANOTHER MANUFACTURER. THE BREAKAGES OF THE SCREWDRIVERS OCCURRED ONLY AT THE RIGHT L5 SITE. AFTER PREPARATION WITH AN UNDERSIZED SOLID TAP, INSERTION OF A D 9X55 SCREW WAS ATTEMPTED; DURING THE FIRST TURNS, THE FIRST SCREWDRIVER BROKE INSIDE THE SCREW. A D 8X55 SCREW WAS THEN REQUESTED, BUT TWO ADDITIONAL SCREWDRIVERS BROKE DURING INSERTION ATTEMPTS. FINALLY, A D 9X50 SCREW WAS IMPLANTED; DURING THE FINAL TURN, THE FOURTH SCREWDRIVER ALSO BROKE. THE SURGERY WAS COMPLETED AS THE FINAL SCREWDRIVER BREAKAGE OCCURRED WHEN THE LAST SCREW WAS ALREADY IMPLANTED. TAPPING WAS PERFORMED FOR ALL SCREWS AND FOR THE FULL INTENDED SCREW LENGTH. NO BROKEN FRAGMENTS WERE LEFT INSIDE THE PATIENT. THE EVENT CAUSED AN ESTIMATED SURGICAL DELAY OF APPROXIMATELY 30D 40 MINUTES DURING AN OVERALL SURGERY LASTING APPROXIMATELY 5 HOURS.