MINI TIGHTROPE REPAIR

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: G3, H3, H6. THE COMPLAINT ALLEGATION IS CONFIRMED BASED ON PHOTOGRAPHIC EVIDENCE OF AN AR-8911DS, BATCH 32375, THAT DISPLAYS. 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.

Description of Event or Problem

ON 12/04/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT FOR AN AR-8911DS MINI TIGHTROPE REPAIR KIT, DURING BUTTON REDUCTION, THE SUTURE BROKE. IT WAS REPORTED THAT BASED ON WHAT WAS OBSERVED, EXCESSIVE FORCE WAS APPLIED WHEN USING TWO FORCEPS. THIS WAS DISCOVERED DURING A LISFRANC FRACTURE FIXED WITH TWO TIGHTROPES PROCEDURE WITH NO PATIENT HARM. THE CASE WAS COMPLETED WITH ANOTHER TIGHTROPE.

Additional Manufacturer Narrative

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