Arthrex® AR-2280Recalls & reported problems
Arthrex, Inc. · BUTTON INSERTER/SUTURE KIT · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867097896), received between Sep 12, 2024 and Sep 12, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (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
- Material Split, Cut or Torn1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 12, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
ON 8/26/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT TIGHTROPE SUTURES RIPPED DURING TENSIONING. AN AR-1670PS PEEK TENODESIS SCREW WAS OPENED, AND IT WAS STRIPPED DURING INSERTION. THE CASE WAS COMPLETED USING AN AR-2280 KNOTLESS DISTAL BICEPS AND A NEW SCREW. THIS WAS DISCOVERED DURING A DISTAL BICEP PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 9/9/2024: THE SUTURES OF A KNOTLESS BICEP BUTTON FROM AN AR-2280 RIPPED, AND THE BICEP WAS UNABLE TO BE TIGHTENED. EVERYTHING WAS SUCCESSFULLY REMOVED FROM INSIDE THE PATIENT. AR-1670PS PEEK TENODESIS SCREW DID NOT BREAK, ONLY STRIPPED DURING INSERTION. THE CASE WAS COMPLETED USING A NEW AR-1670PS PEEK TENODESIS SCREW AND AR-2280 KNOTLESS DISTAL BICEPS. ADDITIONALLY, DURING THE PROCEDURE, WHEN AN AR-1255-18 SUTURE PASSING WIRE WAS OPENED, IT WAS MISSING THE EYELET LOOP AT THE END. A SECOND AR-1255-18 SUTURE PASSING WIRE WAS USED INSTEAD.
Patient problems: Insufficient Information
MAUDE report 20200954 ↗
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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.
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