Arthrex® AR-8924SSRecalls & reported problems
Arthrex, Inc. · K-LESS T-ROPE IMP ONLY, SYN REPR, SS · Class 2 · Implant
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867265592), received between Jan 22, 2024 and May 21, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Inadequacy of Device Shape and/or Size1
- Material Rupture1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 21, 2025Material Rupture; Material Rupture
ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8924SS KNOTLESS TIGHTROPE IMPLANT RUPTURES THE LOOP TRACTION SUTURE FROM THE BASE OF THE BUTTON SO THEY FAIL TO REDUCE IT. THIS WAS DISCOVERED DURING USE IN A PROCEDURE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22061947 ↗MalfunctionApr 19, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT DURING A DEX PROCEDURE, THE LOOP SUTURE WAS CUT WHEN THE SURGEON WAS PASSING THE TIGHTROPE THROUGH THE FIBULA NAIL. FRAGMENT WAS RETRIEVED AND THE CASE WAS COMPLETED BY USING A NEW AR-8924SS.
Patient problems: Insufficient Information
MAUDE report 19144810 ↗MalfunctionJan 22, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
ON 1/3/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT DURING A PROCEDURE ON (B)(6) 2023, WHEN PLACING THE KNOTLESS TIGHTROPE, AR-8924SS, INTO THE PATIENT, IT WAS FOUND THAT IT WAS TOO SHORT. THE TIGHTROPE WAS DISCARDED, AND ANOTHER ONE WAS OPENED AND USED TO COMPLETE THE CASE WITH NO ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18554674 ↗
Other WASHER, BOLT NUT devices
- FIBULINK FGS-1000Synthes GmbH · Washer, Bolt Nut117 reports
- Arthrex® AR-2372BLOArthrex, Inc. · WASHER, BOLT NUT91 reports
- Arthrex® AR-8925SSArthrex, Inc. · WASHER, BOLT NUT79 reports
- Arthrex® AR-8925TArthrex, Inc. · WASHER, BOLT NUT71 reports
- Arthrex® AR-8926TArthrex, Inc. · WASHER, BOLT NUT61 reports
- RipCord STA001KTrimed, INC. · WASHER, BOLT NUT1 recall2 reports
- Arthrex® AR-7000-18TArthrex, Inc. · WASHER, BOLT NUT1 recall0 reports
- Arthrex® AR-8926SSArthrex, Inc. · WASHER, BOLT NUT35 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.