inforMED
InjuryHTN

KNOTLESS AC TIGHTROPE REPAIR SYSTEM

Received Mar 6, 2026 · Event occurred Feb 12, 2026

Report 1220246-2026-01277 · MDR key 24531207

Device

Generic name

Washer, Bolt, Nut

Manufacturer

Arthrex, Inc.

Catalog number

AR-2371BL

Lot number

UNK

Product problems

  • Break
  • Material Split, Cut or Torn

Patient

NA · Unknown

  • Failure of Implant

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

IT WAS REPORTED THAT AFTER A SURGERY THE KNOTLESS AC TIGHTROPE AR-2371BL TORE AND THE CLAVICLE RE-ASCENDED. NO FURTHER INFORMATION WAS PROVIDED. UPDATE 19-FEB-2026. IT WAS CONFIRMED THAT THE INITIAL SURGERY WAS PERFORMED IN (B)(6) 2025 AND THE INCIDENT OCCURRED WHEN THE PATIENT ALLEGEDLY "CAUGHT A TELEVISION". THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2026. THE PATIENT WAS TREATED WITH AUTOGRAFT + FIBERTAPE + HOOK PLATE.