KNOTLESS T-ROPE SYN-DESMOSIS REPR TI

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: G3, H3, H6. BASED ON THE INFORMATION PROVIDED WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR OF THE DEVICE DUE TO EXCESSIVE FORCE USED DURING SUTURE PASSING/TIGHTENING /TENSIONING.

Additional Manufacturer Narrative

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

Description of Event or Problem

ON 6 JANUARY 2026, A DISTRIBUTOR REPORTED VIA EMAIL THAT AN AR-8926T TIGHTROPE (LOT 33696) WAS UNABLE TO SELF-LOCK AT THE END OF THE PROCEDURE WHEN THE EXCESS PULLING SUTURE WAS BEING CUT. THE ISSUE WAS DETECTED DURING A SYNDESMOSIS REPAIR. THE SURGEON AND DISTRIBUTOR REPRESENTATIVE CONFIRMED THAT THE SUTURE REMAINED INTACT THROUGHOUT BUTTON DEPLOYMENT, TENSIONING, AND TRIMMING; HOWEVER, THE TIGHTROPE FAILED TO LOCK AS EXPECTED. THE SURGEON SUBSEQUENTLY REMOVED THE AFFECTED TIGHTROPE BY CUTTING THE SUTURE AND PROCEEDED WITH AN ADDITIONAL TIGHTROPE, MANUALLY TYING A KNOT TO AVOID ANY POTENTIAL LOCKING DEFECT OCCURRING AGAIN IN THE SAME CASE. THE DEFECTIVE UNIT MAY HAVE NOT BEEN COMPLETE IN ITS ORIGINAL PACKAGING. NO PATIENT HARM WAS REPORTED.