SYNDESMOSIS TIGHTROPE PRO IMPLANT, TI
Received Jun 26, 2026 · Event occurred Jun 3, 2026
Report 1220246-2026-03536 · MDR key 25635043
Device
Generic name
Washer, Bolt, Nut
Manufacturer
Arthrex, Inc.Model number
SYNDESMOSIS TIGHTROPE PRO IMPLANT, TICatalog number
AR-9925T
Lot number
15611229
Product problems
- Detachment of Device or Device Component
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 04-JUN-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-9925T SYNDESMOSIS TIGHTROPE PRO IMPLANT HAD THE BUTTON FALL OFF OF THE INSERTER AND COULD NOT BE REATTACHED. THIS WAS DISCOVERED DURING A SYNDESMOSIS REPAIR PROCEDURE WITH NO PATIENT HARM REPORTED. NO PROCEDURAL DELAY WAS EXPERIENCED AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE CASE WAS COMPLETED USING AN AR-8925T SYNDESMOSIS TIGHTROPE XP.