inforMED
MalfunctionHTN

KNOTLESS AC TIGHTROPE OPEN REPAIR IMPLAN

Received Mar 19, 2026 · Event occurred Feb 26, 2026

Report 1220246-2026-01530 · MDR key 24640529

Device

Generic name

Washer, Bolt, Nut

Manufacturer

Arthrex, Inc.

Catalog number

AR-2372BLO

Lot number

15415161

Product problems

  • Detachment of Device or Device Component

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

ON 27-FEB-2026, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT AN AR-2372BLO KNOTLESS AC TIGHTROPE BUTTON CAME OFF DURING INSERTION. THE SURGEON ATTEMPTED TO DEPLOY THE BUTTON MULTIPLE TIMES, BUT IT WOULD NOT GRIP AND DETACHED IMMEDIATELY. THE SURGERY WAS COMPLETED USING ANOTHER AR-2372BLO KNOTLESS AC TIGHTROPE DEVICE. THIS ISSUE WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2026. NO SIGNIFICANT SURGICAL DELAY WAS REPORTED, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING OR AFTER THE PROCEDURE RELATED TO THIS ISSUE.

Additional Manufacturer Narrative

INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.