Arthrex® AR-2324KPSLCRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00888867351332), received between Mar 28, 2022 and Sep 16, 2025 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2025Use of Device Problem; Use of Device Problem

  ON 08/27/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT (4) AR-2324KPSLC PEEK KNOTLESS SWIVELOCK® SUTURE ANCHOR FAILED. THIS OCCURRED DURING A REVISION ACHILLES PROCEDURE ON (B)(6) 2025. WHEN PASSING THE REPAIR STITCH INSTEAD OF CINCHING DOWN AS IT SHOULD, IT WOULD LOOSEN UP. THREE OF THESE FOUR DEVICES FAILED INSIDE THE PATIENT; THE FOURTH WAS TESTED IN THE CASE AND ALSO FAILED. TWO OF THESE DEVICES REMAINED IN THE PATIENT AND WERE SECURED. ADDITIONALLY, A DEVICE FROM ANOTHER MANUFACTURER WAS USED TO COMPLETE THE CASE. THERE WAS A SLIGHT DELAY IN THE PROCEDURE THAT DID NOT REQUIRE ADDITIONAL ANESTHESIA.

  Patient problems: Insufficient Information

  MAUDE report 23061761 ↗
• MalfunctionSep 16, 2025Use of Device Problem; Use of Device Problem

  ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT (4) AR-2324KPSLC PEEK KNOTLESS SWIVELOCK® SUTURE ANCHOR FAILED. THIS OCCURRED DURING A REVISION ACHILLES PROCEDURE ON (B)(6) 2025. WHEN PASSING THE REPAIR STITCH INSTEAD OF CINCHING DOWN AS IT SHOULD, IT WOULD LOOSEN UP. THREE OF THESE FOUR DEVICES FAILED INSIDE THE PATIENT; THE FOURTH WAS TESTED IN THE CASE AND ALSO FAILED. TWO OF THESE DEVICES REMAINED IN THE PATIENT AND WERE SECURED. ADDITIONALLY, A DEVICE FROM ANOTHER MANUFACTURER WAS USED TO COMPLETE THE CASE. THERE WAS A SLIGHT DELAY IN THE PROCEDURE THAT DID NOT REQUIRE ADDITIONAL ANESTHESIA.

  Patient problems: Insufficient Information

  MAUDE report 23061753 ↗
• MalfunctionSep 16, 2025Use of Device Problem; Use of Device Problem

  ON 08/27/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT (4) AR-2324KPSLC PEEK KNOTLESS SWIVELOCK® SUTURE ANCHOR FAILED. THIS OCCURRED DURING A REVISION ACHILLES PROCEDURE ON (B)(6) 2025. WHEN PASSING THE REPAIR STITCH INSTEAD OF CINCHING DOWN AS IT SHOULD, IT WOULD LOOSEN UP. THREE OF THESE FOUR DEVICES FAILED INSIDE THE PATIENT; THE FOURTH WAS TESTED IN THE CASE AND ALSO FAILED. TWO OF THESE DEVICES REMAINED IN THE PATIENT AND WERE SECURED. ADDITIONALLY, A DEVICE FROM ANOTHER MANUFACTURER WAS USED TO COMPLETE THE CASE. THERE WAS A SLIGHT DELAY IN THE PROCEDURE THAT DID NOT REQUIRE ADDITIONAL ANESTHESIA.

  Patient problems: Insufficient Information

  MAUDE report 23061741 ↗
• MalfunctionSep 16, 2025Use of Device Problem; Use of Device Problem

  ON 08/27/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT (4) AR-2324KPSLC PEEK KNOTLESS SWIVELOCK® SUTURE ANCHOR FAILED. THIS OCCURRED DURING A REVISION ACHILLES PROCEDURE ON (B)(6) 2025. WHEN PASSING THE REPAIR STITCH INSTEAD OF CINCHING DOWN AS IT SHOULD, IT WOULD LOOSEN UP. THREE OF THESE FOUR DEVICES FAILED INSIDE THE PATIENT; THE FOURTH WAS TESTED IN THE CASE AND ALSO FAILED. TWO OF THESE DEVICES REMAINED IN THE PATIENT AND WERE SECURED. ADDITIONALLY, A DEVICE FROM ANOTHER MANUFACTURER WAS USED TO COMPLETE THE CASE. THERE WAS A SLIGHT DELAY IN THE PROCEDURE THAT DID NOT REQUIRE ADDITIONAL ANESTHESIA.

  Patient problems: Insufficient Information

  MAUDE report 23061706 ↗
• MalfunctionJan 21, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 12/26/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2324KPSLC PEEK KNOTLESS SWIVELOCK THE SUTURES GOT STUCK IN THE MECHANISM ATTEMPTING TO CONVERT. A BUNCH OF FRICTION WAS MET AFTER WHICH THE SHUTTLE LOOP SNAPPED, AND THE CONVERSION WAS UNSUCCESSFUL. A PUNCHING 3.5 PUSHLOCK WAS OPENED, AND THE REPAIR STITCH, WHICH WAS STILL PAST THROUGH TISSUE, WAS LOADED INTO THE ANCHOR TO COMPLETE THE REPAIR OF THE DOG EAR. THIS WAS DISCOVERED DURING A SUPRASPINATUS REPAIR PROCEDURE ON (B)(6) 2024. THE PATIENT WAS NOT AFFECTED. THE CASE WAS DELAYED FIVE MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21197413 ↗
• MalfunctionJun 6, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THE AR-2324KPSLC HAD A MISLOADED TAIL, IT WAS UNWOUND. ADDITIONAL INFORMATION 4/8/2021 IT WAS REPORTED THAT DURING BICEPS TENODESIS, WHEN INSERTED INTO THE BONE AFTER PULLING OFF THE ORANGE TAB THERE WERE ONLY TWO TALES. THE PASSING SUTURE TO THE KNOTLESS CORKSCREW WAS ALREADY COMPLETELY THROUGH THE EYELET. THE SURGEON WAS PLANNING TO USE THE KNOTLESS ADDITIONAL TO TAG THE SUPERIOR ASPECT OF THE SUBSCAP. BECAUSE IT WAS UNDONE, THIS COULD NOT BE DONE AND THE CASE WAS COMPLETED USING TWO ADDITIONAL ANCHORS TO REPAIR THE SUBSCAP.

  Patient problems: Insufficient Information

  MAUDE report 19477161 ↗
• MalfunctionMay 8, 2024Unintended Movement; Unintended Movement

  ON 12/2/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2324KPSLC PEEK KNOTLESS SWIVELOCK ANCHOR AND EYELET WERE LOOSE DURING TENSIONING. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2022. CASE WAS COMPLETED WITH ANOTHER AR-2324KPSLC PEEK KNOTLESS SWIVELOCK ANCHOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19267847 ↗
• MalfunctionApr 29, 2024Defective Device; Defective Device

  ON (B)(6) 2021 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-2324KPSLC KNOTLESS SWIVELOCK, SUTURE MECHANISM BACKED OUT OF THE EYELET AS THE SURGEON WAS TENSIONING THE IMPLANT. THE ENTIRE AR-2324KPSLC WAS REMOVED. THIS WAS DISCOVERED DURING USE IN A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2021. THE CASE WAS COMPLETED USING A NEW AR-2324KPSLC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19200505 ↗
• MalfunctionApr 11, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 11/12/2021 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-2324KPSLC KNOTLESS SWIVELOCK, SUTURE MECHANISM BACKED OUT OF THE EYELET AS THE SURGEON WAS TENSIONING THE IMPLANT. THE ENTIRE AR-2324KPSLC WAS REMOVED. THIS WAS DISCOVERED DURING USE IN A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2021. THE CASE WAS COMPLETED USING A NEW AR-2324KPSLC.

  Patient problems: Insufficient Information

  MAUDE report 19086815 ↗
• MalfunctionMar 7, 2024Break; Break

  ON 02/21/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1204FF FLIPCUTTER III DRILL WAS TWISTED AT THE TIP. THE WELD WAS BROKEN AND EASIER TO REMOVE. AN AR-2324KPSLC PEEK KNOTLESS SWIVELOCK SUTURE ANCHOR, 4.75 X 19.1 M M, VE5 WAS BROKEN ON THE INTERNAL BRACE ON INSERTION. THIS WAS DISCOVERED DURING AN ACL RECONSTRUCTION. THE CASE WAS COMPLETED WITH ANOTHER DEVICE WITH ANOTHER AR-1204FF FLIPCUTTER III DRILL AND AR-2324KPSLC PEEK KNOTLESS SWIVELOCK SUTURE ANCHOR, 4.75 X 19.1 M M, VE5 WITH NO PATIENT HARM. ALL MATERIALS WERE REMOVED AND DISCARDED BY THE FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18858402 ↗
• MalfunctionMay 15, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT (2) AR-2324KPSLC PEEK KNOTLESS SWIVELOCK EYELET BROKE WHILE TENSIONING THE REPAIR SUTURE. THE ANCHOR WAS IMPLANTED, AND THE CASE WAS COMPLETED. THIS WAS DISCOVERED DURING A KNOTLESS SPEEDBRIDGE WITH CANOPY AUGMENT PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16931293 ↗
• MalfunctionMar 7, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 02/17/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-2324KPSLC PEEK KNOTLESS SWIVELOCK'S EYELET FELL OFF. THIS OCCURRED DURING AN ACL RECONSTRUCTION ON (B)(6) 2023 WHEN BACKING UP THE GRAFT AND INSERTING THE ANCHOR THE EYELET FELL OFF. THE METAL DAMAGED THE SUTURE MAKING THE DEVICE UNUSABLE. THIS STEP OF THE CASE ENDED UP BEING SKIPPED AS IT WAS USED AS ADDITIONAL SUPPORT. THERE WAS NO PATIENT EFFECT.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16494276 ↗
• MalfunctionMar 28, 2022Material Frayed; Retraction Problem

  ON 03/10/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2324KPSLC PEEK KNOTLESS SWIVELOCK SEEMS TO BE FRAYING AND CUTTING AN AR-7535 FIBERLINK SUTURE TAPE SUTURE WHEN THE SUTURE COMES IN CONTACT WITH THE METAL DRIVER DURING TENSIONING. THIS WAS DISCOVERED DURING A REVISION SUBPEC TENODESIS PROCEDURE ON (B)(6) 2022. THIS ISSUE HAS CAUSED THE BICEP TO RETRACT AND CAUSING PATIENT PAIN. THE ORIGINAL PROCEDURE WAS A BICEPS LOOP N TAK. SURGEON WAS ABLE TO CORRECT ISSUE WITH A 2.6 KNOTLESS FIBERTAK SUBPC ONLAY.

  Patient problems: Pain

  MAUDE report 13928473 ↗