MalfunctionHTN
SYNDESMOSIS TIGHTROPE PRO IMPLANT, TI
Received Jul 13, 2026 · Event occurred Jun 16, 2026
Report 1220246-2026-03731 · MDR key 25795692
Device
Generic name
Washer, Bolt, Nut
Manufacturer
Arthrex, Inc.Model number
SYNDESMOSIS TIGHTROPE PRO IMPLANT, TICatalog number
AR-9925T
Lot number
15611230
Product problems
- Break
Patient
NA · Unknown
- Insufficient Information
Narrative
Description of Event or Problem
ON 16-JUN-2026, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-9925T SYNDESMOSIS TIGHTROPE PRO IMPLANT, TITANIUM EXPERIENCED THE MIDDLE ROD BREAKING APART DURING AN ANKLE TENODESIS REPAIR. THE DEVICE WAS STILL USABLE, AND THE CASE WAS COMPLETED SUCCESSFULLY WITH MINIMAL DELAY.
Additional Manufacturer Narrative
INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.