TIGHTROPE XP BUTTRESS PLATE IMPLANT SYS

Description of Event or Problem

ON 02-FEB-2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT DURING A SYNDESMOSIS REPAIR PROCEDURE ON (B)(6) 2026, BOTH AN AR-8959TDS SYNDESMOSIS TIGHTROPE XP BUTTRESS PLATE IMPLANT SYSTEM AND AN AR-8925SS SYNDESMOSIS TIGHTROPE XP WERE INSERTED THROUGH THE PLATE WITH THE BUTTONS FLIPPED AS INTENDED. WHEN THE INCLUDED TENSIONING HANDLES WERE USED, THE SUTURES BROKE BEFORE ADEQUATE REDUCTION COULD BE ACHIEVED. THE SAME ISSUE OCCURRED WITH BOTH INITIAL IMPLANTS. THE SURGEON THEN OPENED TWO ADDITIONAL SINGLE-IMPLANT KITS, AND THE SUTURE BREAKAGE RECURRED WITH ONE OF THOSE IMPLANTS AS WELL. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 05-FEB-2026: ON OPENING THE AR-8959TDS SYNDESMOSIS TIGHTROPE XP BUTTRESS PLATE IMPLANT SYSTEM (LOT 15119012), THE TWO INCLUDED TIGHTROPE IMPLANTS EXPERIENCED SUTURE BREAKAGE DURING TENSIONING. THE FACILITY THEN OPENED TWO AR-8925SS SYNDESMOSIS TIGHTROPE XP IMPLANTS, AND ONE OF THESE (LOT 15292557) EXHIBITED THE SAME SUTURE-FRACTURE ISSUE. THE SURGEON REPORTED THAT THE LATERAL ROUND BUTTON WAS GUIDED TO THE PLATE, AND APPROXIMATELY TWO TO THREE TENSIONING CYCLES WERE PERFORMED BEFORE THE SUTURES FRACTURED. TENSIONING WAS APPLIED ALONG THE IMPLANT, AND NO EXCESSIVE FORCE WAS NOTED. ALL DETACHED SUTURES WERE RETRIEVED, AND ALL THREE CONSTRUCTS WERE REMOVED AND REPLACED. THE CASE WAS COMPLETED USING THE 2-HOLE BUTTRESS PLATE FROM AR-8959TDS AND TWO ADDITIONAL AR-8925SS IMPLANTS (LOTS 15283929 AND 15389071). NO ALTERNATIVE FIXATION WAS ATTEMPTED. THE BONE TUNNEL WAS CREATED USING THE 3.7 MM DRILL BIT PROVIDED IN THE KIT. BONE QUALITY WAS NOT ASSESSED AS POOR. NO PATIENT ADVERSE EVENTS WERE REPORTED. THE PROCEDURE WAS DELAYED BY APPROXIMATELY ONE HOUR, AND ADDITIONAL ANESTHESIA WAS ADMINISTERED; HOWEVER, THE DURATION IS UNKNOWN.

Additional Manufacturer Narrative

INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.