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

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 08/05/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-8925T SYNDESMOSIS TIGHTROPE XP SNAPPED WHEN THE SURGEON WENT TO TIGHTEN THE SUTURES DOWN ONTO THE BUTTON; THE INITIAL SUTURE SNAPPED. FURTHER ATTEMPTS TO SECURE IT CAUSED ADDITIONAL SUTURES TO BREAK, LEAVING NO REMAINING SUTURES FOR FIXATION. THE BUTTON AND BROKEN SUTURES WERE REMOVED FROM THE PATIENT, AND THE CASE WAS COMPLETED WITH A REPLACEMENT AR-8925T SYNDESMOSIS TIGHTROPE XP. NO SIGNIFICANT DELAY OR ADDED ANESTHESIA WAS ADMINISTERED, AND NO ADVERSE EFFECTS WERE REPORTED. THIS WAS DISCOVERED DURING AN ANKLE FRACTURE PROCEDURE ON (B)(6) 2025.

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 OF THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR OF THE DEVICE DUE TO EITHER EXCESSIVE FORCE USED DURING SUTURE PASSING OR THE DEVICE COMING IN CONTACT WITH ANOTHER DEVICE DURING USE.