SYNDESMOSIS TIGHTROPE PRO IMPLANT, TI
Received Jul 8, 2026 · Event occurred Jun 8, 2026
Report 1220246-2026-03653 · MDR key 25746604
Device
Generic name
Washer, Bolt, Nut
Manufacturer
Arthrex, Inc.Model number
SYNDESMOSIS TIGHTROPE PRO IMPLANT, TICatalog number
AR-9925T
Lot number
15611226
Product problems
- Positioning Failure
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 12-JUN-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT A QTY. 2 OF AR-9925T SYNDESMOSIS TIGHTROPE PRO IMPLANTS WOULD NOT ALLOW THE BUTTON TO FLIP ON THE MEDIAL SIDE. THIS WAS DISCOVERED DURING A SYNDESMOSIS ORIF ANKLE FRACTURE PROCEDURE WITH NO PATIENT HARM. NO PROCEDURAL DELAY WAS EXPERIENCED, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE CASE WAS COMPLETED USING AN AR-8925T SYNDESMOSIS TIGHTROPE XP WITHOUT ANY FURTHER ISSUES.