KNOTLESS T-ROPE SYN-DESMOSIS REPR TI

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: G3, H3, H6. THE COMPLAINT ALLEGATION IS CONFIRMED BASED ON PHOTOGRAPHIC EVIDENCE OF AN AR-8926T, BATCH 33696, THAT DISPLAYED A KNOTLESS T-ROPE THAT WAS SIGNIFICANTLY FRAYED. 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 (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-8926T KNOTLESS T-ROPE SYNDESMOSIS REPAIR HAD BEEN SHREDDED BEFORE FINAL TENSIONING. THEY HAD TO OPEN A NEW ONE AND CUT OUT THE FAULTY ONE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED ON 12/09/2025. ADDITIONAL INFORMATION WAS RECEIVED ON 10-DEC-2025: THIS ISSUE WAS DISCOVERED DURING A SYNDESMOSIS PROCEDURE, RESULTING IN AN APPROXIMATE FIVE-MINUTE DELAY WHILE A NEW PRODUCT WAS OPENED. ALL DETACHED FRAGMENTS WERE ACCOUNTED FOR AND RETRIEVED FROM THE PATIENT.