Arthrex® AR-2324PSLC-2Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867251243), received between Sep 19, 2022 and Jun 19, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED DURING A ROTATOR CUFF REPAIR PROCEDURE, THE SURGEON INSERTED AND SEATED THE AR-2324PSLC-2 DOUBLE LOADED PEEK SWIVELOCK, (LOT: 12900335) AS THE SURGEON WAS TIGHTENING DOWN ON THE WHITE SUTURE, HE NOTICE THE SUTURE WAS CUT FROM THE EYELET. THE BROKEN SUTURE WAS REMOVED FROM THE PATIENT. THE BLUE SUTURE WAS USE TO SECURE THE AR-2324PSLC-2. THE SURGEON USED A SECOND AR-2324PSLC-2 (LOT: 13262585) AND THE SAME ISSUE OCCURRED. THE CASE WAS COMPLETED WITHOUT PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19570117 ↗
• MalfunctionApr 25, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED DURING A ROTATOR CUFF REPAIR PROCEDURE, THE SURGEON INSERTED AND SEATED THE AR-2324PSLC-2 DOUBLE LOADED PEEK SWIVELOCK, (LOT: 12900335) AS THE SURGEON WAS TIGHTENING DOWN ON THE WHITE SUTURE, HE NOTICE THE SUTURE WAS CUT FROM THE EYELET. THE BROKEN SUTURE WAS REMOVED FROM THE PATIENT. THE BLUE SUTURE WAS USE TO SECURE THE AR-2324PSLC-2. THE SURGEON USED A SECOND AR-2324PSLC-2 (LOT: 13262585) AND THE SAME ISSUE OCCURRED. THE CASE WAS COMPLETED WITHOUT PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19181625 ↗
• MalfunctionApr 12, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 09/21/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT QTY. 3 OF AN AR-2324PSLC-2 DOUBLE LOADED SWIVELOCKS BROKE DURING LATERAL ROW IMPLANTATION. FIRST THE EYELET POPPED OFF WHILE THE SURGEON WAS PULLING THE ANCHOR OVER TO THE HOLE. THEN UNWOUND THE EYELET SUTURE AND PULLED TIGHT TO ¿RE-SEAT¿ THE EYELET, CLAMPED THE SUTURE SO THE EYELET WOULDN'T SLIP OFF AGAIN. AS THE SURGEON STARTED TO PULL THE ANCHOR OVER TO THE HOLE A 2ND TIME, THE EYELET SUTURE SEVERED AT THE EYELET/DRIVER ATTACHMENT. THIS OCCURRED 3 TIMES IN A ROW IN THE EXACT SAME SEQUENCE. THE CASE WAS COMPLETED BY SWITCHING TO A STANDARD SWIVELOCK WHICH IMPLANTED PERFECTLY WITH NO ADDITIONAL ISSUE. NO PATIENT HARM ADDITIONAL INFORMATION PROVIDED 09/21/21: THE PROCEDURE BEING PERFORMED WAS A ROTATOR CUFF REPAIR. THE CASE WAS COMPLETED BY USING AN AR-2324PSLC. IMAGES OF THE DEVICE ARE ATTACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19097146 ↗
• MalfunctionFeb 26, 2024Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2324PSLC-2 SWIVELLOCK ANCHOR BROKE UPON INSERTION. THE PATIENT WAS NOT HARMED AND THE PRODUCT WAS DISCARDED. THE SAME ANCHOR WITH A DIFFERENT LOT WAS USED TO COMPLETE THE REPAIR. CASE WAS DELAYED 5 MINUTES BUT NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18779537 ↗
• MalfunctionSep 19, 2022Break

  IT WAS REPORTED ON (B)(6) 2022 BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2324PSLC-2 SWIVELLOCK SUTURES BROKE-OFF AT THE PEEK TIP. THIS WAS DISCOVERED DURING A CASE AND BROKE INSIDE THE PATIENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15445770 ↗