SYNDESMOSIS TIGHTROPE PRO IMPLANT, TI
Received Jun 15, 2026 · Event occurred May 29, 2026
Report 1220246-2026-03412 · MDR key 25507890
Device
Generic name
Washer, Bolt, Nut
Manufacturer
Arthrex, Inc.Model number
SYNDESMOSIS TIGHTROPE PRO IMPLANT, TICatalog number
AR-9925T
Lot number
15559127
Product problems
- Use of Device Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
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 29-MAY-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9925T TIGHTROPE'S BLACK DIAL POPPED OUT THE BACK DURING USE. WHEN PUSHING PAST THE FAR CORTEX, THE BLACK DIAL STARTED POPPING OUT THE BACK. WAS REINSERTED THEN TRIED TO REMOVE TIGHTROPE TO REDRILL AND BLACK DIAL FELL OUT AGAIN AND ONTO THE FLOOR. NOTICED DURING A CASE, NEW DEVICE OPENED, AND CASE COMPLETED WITH NO PATIENT EFFECT.