KNOTLESS MINI TR IMPLANT, 2.7MM, TI
Received Mar 25, 2026 · Event occurred Oct 8, 2025
Report 1220246-2026-01651 · MDR key 24689668
Device
Generic name
Washer, Bolt, Nut
Manufacturer
Arthrex, Inc.Model number
KNOTLESS MINI TR IMPLANT, 2.7MM, TICatalog number
AR-8908DS
Lot number
15314344
Product problems
- Material Twisted/Bent
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
ON 05-MAR-2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-8908DS KNOTLESS MINI TIGHTROPE IMPLANT SYSTEM HAD THE SUTURE NOT TENSION NORMALLY. THIS WAS DISCOVERED DURING A LISFRANC ORIF PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 11-MAR-2026: THE PROBLEM WAS IDENTIFIED INSIDE THE PATIENT WHEN THE TIGHTROPE DEVICE WAS TIGHTENED. AS TENSION WAS APPLIED, THE DEVICE BUNCHED UP ON ONE OF THE STRANDS, RESULTING IN UNEVEN TENSION AND PREVENTING THE CONSTRUCT FROM FULLY TIGHTENING. THE SUTURE BECAME DAMAGED AS A DIRECT RESULT OF THE ISSUE. THE AFFECTED IMPLANT WAS REMOVED, AND THE CASE WAS COMPLETED USING A SECOND AR-8908DS DEVICE. THE EVENT CAUSED ONLY A BRIEF DELAY OF A FEW MINUTES, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING OR FOLLOWING THE PROCEDURE.
Additional Manufacturer Narrative
INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.