Arthrex® AR-2324KPSPRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888867384552), received between Oct 9, 2023 and Feb 25, 2026 — classified as 1 injury, 6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 25, 2026Use of Device Problem

  ON 11-FEB-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-2324KPSP KNOTLESS SWIVELLOCK KNOTLESS MECHANISM PULLED THROUGH THE ANCHOR WHEN BEING CONVERTED. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. THE CASE WAS COMPLETED USING ANOTHER ANCHOR AND REINSERTING IT. THERE WAS A 10-MINUTE DELAY TO THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24443139 ↗
• InjuryNov 25, 2025Break; Break

  ON 07 NOVEMBER 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2324KPSP, SWIVELOCK SP PEEK KL 4.75MM WAS REPORTED TO HAVE BROKEN DURING USE. THIS OCCURRED ON (B)(6) 2025 DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT THE PEEK TIP DID NOT PIERCE THROUGH BONE AND EYELET CAME AWAY FROM INSERTION HANDLE. THE CASE WAS COMPLETED SUCCESSFULLY USING ANOTHER ANCHOR. THERE WAS CASE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23649825 ↗
• MalfunctionNov 13, 2025Break; Break

  ON 07 NOVEMBER 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2324KPSP, SWIVELOCK SP PEEK KL 4.75 MM WAS REPORTED TO HAVE BROKEN DURING USE. THIS OCCURRED ON (B)(6) 2025 DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT THE PEEK TIP DID NOT PIERCE THROUGH CORTICAL BONE: INSTEAD APPEARS BLUNTED. EYELET CAME AWAY FROM INSERTION HANDLE. THE CASE WAS COMPLETED SUCCESSFULLY USING ANOTHER ANCHOR. THERE WAS CASE INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 23541256 ↗
• MalfunctionMay 9, 2025Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED ON 05/08/2025: DURING A ROTATOR CUFF REPAIR ON (B)(6) 2025, THE ISSUE OCCURRED ON THE BACK TABLE RATHER THAN INSIDE THE PATIENT. THE ANCHOR WAS REMOVED, AND NOTHING BROKE INSIDE THE PATIENT. TO COMPLETE THE CASE, A DIFFERENT AR-2324KPSP IMPLANT WAS USED, WITH NO DELAY AND NO ADDITIONAL ANESTHESIA ADMINISTERED. NO INSTRUMENT WAS USED TO PREPARE THE BONE SOCKET, AND THE PATIENT'S BONE QUALITY WAS ASSESSED AS POOR.

  Patient problems: Insufficient Information

  MAUDE report 21995092 ↗
• MalfunctionJan 26, 2024Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT AN AR-2324KPSP 4.75 MM PEEK KNOTLESS SWIVELOCK® ANCHORS SELF-PUNCHING EYELET BROKE. THIS OCCURRED DURING A ROTATOR CUFF PROCEDURE ON (B)(6) 2024 AFTER DOING VERY LIGHT TAPS ON THE BONE. THE BONE WAS THE PERFECT QUALITY TO UTILIZE THE SELF-PUNCH. THE EYELET BROKE INSIDE THE PATIENT BUT ALL THE PIECES WERE RETRIEVED. AN AR-2324PCT PEEK SWIVELOCK WAS USED TO COMPLETE THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 18586288 ↗
• MalfunctionNov 1, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6)2023 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-2324KPSP 4.75 MM PEEK KNOTLESS SWIVELOCK BACKED OUT. THIS OCCURRED DURING AN ALL PROCEDURE ON (B)(6)2023 WHEN THE INSERTER WAS PULLED OUT, AND THE KNOTLESS MECHANISM WAS ALSO PULLED OUT. THE EYELET STAYED IN THE PATIENT, BUT THE ANCHOR WAS REMOVED. THE CASE CONTINUED USING A SECOND AR-2324KPSP AND DRILLING A LITTLE DEEPER. THERE WAS NO HARM TO THE PATIENT. THE PATIENT HAD A GOOD HARD BONE PREPARED FOR INSERTION USING THE DRILL FROM AN AR-1593-P IMPLANT SYSTEM.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18049632 ↗
• MalfunctionOct 9, 2023Defective Device; Defective Device

  ON 9/11/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2324KPSP PEEK KNOTLESS SWIVELOCK SHUTTLE METHOD DID NOT FUNCTION PROPERLY. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 17898444 ↗