Arthrex® AR-2324SLMRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00888867026940), received between Feb 22, 2021 and Dec 8, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 8, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  ON 11/17/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-2324SLM 4.75 MM X 24.5 MM SELF PUNCHING, VENTED, SUTURE ANCHOR, SWIVELOCK SUTURE THAT HOLDS THE TIP OF THE ANCHOR WAS CUT WHEN USING THE ANCHOR. THIS WAS DISCOVERED DURING USE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23743465 ↗
• MalfunctionJan 6, 2025Break; Break

  ON 12/09/2024, IT WAS REPORTED BY A ARTHREX SUBSIDIARY EMPLOYEE VIA SEMS-06730337 THAT AN AR-2324SLM SWIVELLOCK SUTURE BROKE. THIS OCCURRED DURING USE IN A ROTATOR CUFF REPLACEMENT CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21079097 ↗
• MalfunctionNov 14, 2024Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-2324SLM SUTURE ANCHORS SUTURE WAS CUT AND THE ANCHOR WAS RELEASED. THIS OCCURRED DURING A ROTATOR CUFF REPAIR, THAT WAS COMPLETED USING ANOTHER PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20683915 ↗
• MalfunctionMay 15, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ON (B)(6) 2022, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT AN AR-2324SLM SWIVELOCK SUTURES GOT CUT WHEN THE ANCHOR WAS PLACED AND THE BODY OF THE ANCHOR WAS LOWERED TO BE TIED. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2022. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19323459 ↗
• MalfunctionMay 6, 2024Failure to Advance; Failure to Advance

  ON 12/14/2021, IT WAS REPORTED BY A DISTRIBUTOR VIA E-MAIL THAT A AR-2324SLM SWIVELOCK IS NOT WORKING. THIS OCCURRED ON (B)(6) 2021 DURING A PROCEDURE WHEN THE SURGEON INSERTED THE ANCHOR IT WOULD NOT GO DOWN AFTER IMPACTING AND ROLLING THE HANDLE. NO ADDITIONAL INFORMATION. ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED ON 12/15/2021 : THE PROCEDURE BEING PERFORMED WAS A ROTATOR CUFF REPAIR, AND THE CASE WAS COMPLETED USING A NON-ARTHREX DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19248418 ↗
• MalfunctionApr 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2022, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-2324SLM SWIVELOCK ANCHOR SEPARATED FROM SUTURE. THIS WAS DISCOVERED POST OPERATION VIA X-RAY. THE PROCEDURE PERFORMED WAS AN REDUCTION AND FIXATION OF AVULSION FRACTURE OF THE GREATER TUBEROSITY OF HUMERUS AND IT TOOK PLACE ON (B)(6) 2022. A REVISION SURGERY HAS NOT YET OCCURRED BUT IT WILL BE SCHEDULE FOR THE NEAR FUTURE. NO FURTHER INFORMATION HAS BEEN GIVEN AS OF TODAY. ADDITIONAL INFORMATION RECEIVED ON 5/9/2022: SURGEON BECAME AWARE OF DEVICE FAILURE THREE DAYS AFTER THE PROCEDURE ON (B)(6) 2022. REVISION SURGERY HAS YET TO BE SCHEDULE.

  Patient problems: Failure of Implant

  MAUDE report 19195817 ↗
• MalfunctionApr 25, 2024Break; Break

  IT WAS REPORTED ON (B)(6) 2022 BY A FACILITY REPRESENTATIVE VIA EMAIL THAT AN AR-2324SLM SUTURE ANCHOR SUTURE BROKE. THIS WAS DISCOVERED DURING CASE WITH NO PATIENT HARM. PER FACILITY: "THE SUTURES ARE BETRAYED GENTLY, AND AT THE MOMENT OF FIXING THE ANCHORS, ONE OF THE SUTURES IS CUT (IT BREAKS)"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19179833 ↗
• MalfunctionMar 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 2/20/2023, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT AN AR-2324SLM SWIVELOCK SP EYELET TIP OF THE ANCHOR IS RELEASED WHILE THE SUTURE IS TAUT FOR THE DOUBLE ROW AND IT IS NOT FULLY INSERTED, LEAVING THE TIP OUTSIDE THE INSERTION SITE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2022.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information

  MAUDE report 16528633 ↗
• MalfunctionFeb 22, 2021Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, WHEN THE SURGEON IMPLANTED THE AR-2324SLM , THE ANCHOR BROKE AND COMES OFF WHEN SCREWING. ALL FRAGMENTS WERE REMOVED AND THE CASE WAS COMPLETED BY USING ANOTHER AR-2324SLM WITHOUT FURTHER ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 11358067 ↗