Arthrex® AR-2324KPSLC-1Recalls & reported problems
Arthrex, Inc. · 4.75MM PEEK KNOTLESS SWIVELOCK · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867351851), received between Jul 3, 2023 and Apr 17, 2025 — classified as 2 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 17, 2025Break; Break
IT WAS REPORTED THAT DURING A ILIOTIBIAL BAND TENODESIS SURGERY THE EYELET OF THE SWIVELOCK BROKE DURING THE TENSIONING OF THE BLUE SUTURE (FINAL TENSIONING). THE SCREW PART OF THE ANCHOR REMAINED IN THE BONE, BUT THE EYELET BROKE AND CAME OUT, SO THE TENSION GIVEN WAS LOST AND THE WHOLE PROCEDURE HAD TO BE REDONE WITH A NEW ANCHOR. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.
Patient problems: Foreign Body In Patient
MAUDE report 21860629 ↗MalfunctionJul 3, 2023Break; Break
ON 7TH JUNE 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2324KPSLC-1, 4.75MM PEEK KNOTLESS SWIVELOCK HAD ITS EYELET SNAP OFF THE END OF THE SWIVELOCK ON INSERTION. THIS OCCURRED DURING A HIP TENDON REATTACHMENT PROCEDURE ON (B)(6) 2023, WHEN THE SWIVELOCK WAS BEING INSERTED. ALL BROKEN PIECES WERE SUCCESSFULLY RETRIEVED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT HARM BY USING A NEW AR-2324PSLC-1.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17248146 ↗
Other Fastener, fixation, biodegradable, soft tissue devices
- GRYPHON ORTHOCORD 210813Medos International Sàrl · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE712 reports
- HEALIX ADVANCE 222330Depuy Mitek, LLC · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE1 recall607 reports
- HEALIX ADVANCE ORTHOCORD 222295Medos International Sàrl · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE640 reports
- HEALICOIL 72205137Smith & Nephew, Inc. · Fastener, fixation, biodegradable, soft tissue427 reports
- HEALIX ADVANCE ORTHOCORD 222296Medos International Sàrl · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE320 reports
- TWINFIX 72202597Smith & Nephew, Inc. · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE288 reports
- Arthrex® AR-2324BCCArthrex, Inc. · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE254 reports
- HEALIX ADVANCE 222331Depuy Mitek, LLC · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE1 recall196 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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