Arthrex® AR-2324PCTRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867098107), received between Nov 8, 2021 and Nov 26, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 26, 2024Material Twisted/Bent; Material Twisted/Bent

  ON 11/08/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-2324PCT PEEK SWIVELLOCK SUTURE FIBER BECAME KNOTTED. THIS OCCURRED DURING USE. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20784825 ↗
• MalfunctionSep 3, 2024Material Twisted/Bent; Material Twisted/Bent

  ON 8/9/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1255-18 SUTURE PASSING WIRE, NITINOL LOOP PORTION, SNAPPED IN HALF AND AN AR-2324PCT PEEK SWIVELOCK EYELET BENT ON ANCHOR. THE ANCHOR DID NOT BREAK. EVERYTHING WAS REMOVED FROM INSIDE THE PATIENT. THE CASE WAS COMPLETED USING AN AR-2324PSLC EEK-SWIVELOCK C. THIS WAS DISCOVERED DURING A TRICEPS REPAIR PROCEDURE ON (B)(6) 2024. THE CASE WAS DELAYED A FEW MINUTES WITHOUT ADDITIONAL ANESTHESIA.

  Patient problems: Insufficient Information

  MAUDE report 20125382 ↗
• MalfunctionMay 7, 2024Unraveled Material; Unraveled Material

  ON 5/31/20222, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-2324PCT PEEK SWIVELOCK SUTURES PULLED APART AND OUT OF THE ANCHOR WHEN SURGEON WAS TENSIONING. THE SURGEON REMOVED THE ANCHOR AND ALL THE SUTURES AND USED ANOTHER AR-2324PCT PEEK SWIVELOCK TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING AN RCR ON (B)(6) 2022

  Patient problems: Insufficient Information

  MAUDE report 19260879 ↗
• MalfunctionFeb 21, 2024Break; Break

  ON 02/5/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-2324PCT PEEK SWIVELOCK ANCHOR BROKE DURING INSERTION. THE CASE WAS COMPLETED USING ANOTHER AR-2324PCT PEEK SWIVELOCK. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18750294 ↗
• MalfunctionNov 27, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-2324PSLC PEEK SWIVELLOCK ANCHOR BROKE WHILE BEING INSERTED. ALL FRAGMENTS WERE REMOVED. ANOTHER AR-2324PCT SWIVELLOCK ANCHOR BROKE WHILE BEING INSERTED. ALL FRAGMENTS WERE REMOVED. CASE COMPLETED USING A TAP. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18210766 ↗
• MalfunctionNov 8, 2021Break

  ROTATOR CUFF REPAIR- SURGEON HAD PUNCHED A HOLE IN THE HUMERUS. HE THEN WENT TO INSERT A AR-2324PCT INTO THE HOLE. THE HOLE WAS AT A REASONABLY STEEP ANGLE TO THE INSERTION ANGLE OF THE SWIVELOCK. HE INSERTED THE EYELET INTO THE HOLE. THEN THE EYELET BROKE OFF. THE SWIVELOCK INSERTER CONSTRUCT WAS REMOVED FROM THE SHOULDER. THE EYELET REMAINED ATTACHED TO THE FIBERTAPE. ALL PIECES OF THE EYELET APPEAR TO BE PRESENT. IT WAS NOTED THAT THE SWIVELOCK ANCHOR ITSELF WAS NOT ON THE INSERTOR CONSTRUCT WHEN IT WAS RETURNED TO THE SCRUB TABLE. SURGEON NOTIFIED BY REP. SURGEON SEARCHED SHOULDER ARTHROSCOPICALLY AT END OF CASE AND PALPATED SHOULDER. SWIVELOCK NOT FOUND. SURGEON UNCONCERNED, BELIEVED IT MAY HAVE BEEN LOST ON THE OR FLOOR. REP BELIEVES THAT THE SWIVELOCK WAS NOT FAULTY, BUT THAT THE EYELET BREAKAGE WAS LIKELY DUE TO LEVERING FORCE ON SWIVELOCK INSERTER CONSTRUCT WITH THE EYELET IN THE HOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12770772 ↗