K-LESS T-ROPE W/DRV, SYN REPR, TI

Description of Event or Problem

ON 13-FEB-2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-8925T SYNDESMOSIS TIGHTROPE XP, TITANIUM EXPERIENCED AN ISSUE DURING USE. DURING A RIGHT ANKLE FRACTURE PROCEDURE PERFORMED ON (B)(6) 2026, A 1/3 TUBULAR PLATE HAD BEEN FIXATED TO THE BONE. A 3.7 MM DRILL WAS USED TO CREATE A HOLE ACROSS THE DISTAL TIBIA AND FIBULA, AND THE AR-8925T DEVICE WAS INSERTED FROM LATERAL TO MEDIAL AND DEPLOYED. UPON TENSIONING, THE LATERAL BUTTON FAILED TO REDUCE TO THE BONE DUE TO WHAT APPEARED TO BE A KNOT LOCATED MEDIAL TO THE LATERAL BUTTON. ATTEMPTS TO LOOSEN THE KNOT WERE UNSUCCESSFUL, PREVENTING PROPER TENSIONING OF THE DEVICE. THE KNOTTED TIGHTROPE XP WAS CUT AND REMOVED FROM THE PATIENT. THE CASE WAS THEN COMPLETED USING A REPLACEMENT AR-8925T SYNDESMOSIS TIGHTROPE XP, TITANIUM, WITHOUT FURTHER ISSUES. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 19-FEB-2026: THE KNOT WAS IMMEDIATELY IDENTIFIED. WHEN TENSION WAS APPLIED, THE KNOT BEGAN TO FURTHER BALL UP BETWEEN THE BUTTON AND THE BONE. THE MEDIAL SIDE OF THE ANKLE WAS ALREADY SURGICALLY OPEN, ALLOWING THE SURGEON TO DIRECTLY VISUALIZE THE ISSUE WITHOUT THE USE OF FLUOROSCOPY. THE IMPLANT WAS REMOVED, AND THE PROCEDURE WAS COMPLETED USING A REPLACEMENT AR-8925T SYNDESMOSIS TIGHTROPE XP FROM A DIFFERENT LOT. THE CASE WAS DELAYED APPROXIMATELY FIVE MINUTES, AND NO ADDITIONAL ANESTHESIA WAS REQUIRED. THE PATIENT¿S BONE WAS DESCRIBED AS VERY HARD. THE INSTRUMENTS USED INCLUDED THE K-WIRE AND 3.7 MM DRILL BIT PROVIDED IN THE TIGHTROPE XP KIT.

Additional Manufacturer Narrative

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