Arthrex® AR-2324PCT-1Recalls & reported problems
Arthrex, Inc. · PEEK, SWIVELOCK FT, 4.75x19.1MM · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867098114), received between Mar 12, 2025 and Aug 7, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Break1
- Physical Resistance/Sticking1
- Positioning Failure1
Patient problems
- Insufficient Information2
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 7, 2025Positioning Failure; Positioning Failure
ON 22ND JULY 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-2324PCT-1, SUTURE ANCHOR, PEEK SWIVELOCK®, 4.75 MM WITH CLOSED PEEK EYELET AND BLUE FIBERTAPE® LOOP, WAS NOT INSERTING. THIS WAS DETECTED DURING USE IN A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A NEW ANCHOR.
Patient problems: Foreign Body In Patient; Insufficient Information
MAUDE report 22736703 ↗MalfunctionJun 23, 2025Break; Break
ON (B)(6) 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-2324PCT-1, SUTURE ANCHOR, PEEK SWIVELOCK®, 4.75 MM WITH CLOSED PEEK EYELET AND BLUE FIBERTAPE® LOOP, BROKE ON INSERTION AFTER FOLLOWING THE CORRECT INSERTION PREPARATION AND THE BONE WAS NOT HARD. THIS WAS DETECTED DURING USE IN A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS AN ADDITIONAL ANCHOR WAS OPENED AND REPLACED. THE DEVICE BROKE INSIDE THE PATIENT BUT WAS RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22310893 ↗MalfunctionMar 12, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT FOR AN AR-2324PCT, SUTURE ANCHOR, PEEK SWIVELOCK®, 4.75 MM WITH CLOSED PEEK EYELET AND BLUE FIBERTAPE® LOOP, THE SWIVELOCK COLD WELDED. THIS WAS DETECTED DURING USE IN A RCR PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS A NEW ANCHOR WAS USED.
Patient problems: Insufficient Information
MAUDE report 21583932 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page