Arthrex® AR-5815Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867275676), received between Feb 11, 2020 and Oct 20, 2025 — classified as 1 injury, 1 malfunction.

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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 20, 2025Break; Use of Device Problem; Break; Use of Device Problem

  ON 7TH OCTOBER 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-5815, KNOT PUSHER / SUTURE CUTTER, THE NITINOL FLAG SNAPPED SO THE SUTURE COULD NOT BE LOADED. THIS WAS DETECTED DURING USE IN A KNEE MENISCAL REPAIR PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS AN ADDITIONAL SUTURE CUTTER WAS USED.

  Patient problems: Insufficient Information

  MAUDE report 23335205 ↗
• InjuryFeb 11, 2020Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY PROCEDURE, THE SURGEON IMPLANTED A MENISCAL CINCH II PER THE TECHNIQUE. WHEN PUSHING THE KNOTS WITH THE SUTURE TENSIONER/ CUTTER FOR 2-0 FW, AR-5815, THE SUTURE WAS CUT. THE SURGEON REMOVED THE CUT SUTURE FROM THE JOINT WITH FORCEPS. THIS ADDED A 30 MIN DELAY TO THE CASE. THE CASE WAS COMPLETED WITH NO ADVERSE EFFECT TO THE PATIENT. ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED 01/22/20: IT WAS REPORTED DUE TO THE DELAY OF THE CASE, THE PATIENT HAD TO UNDERGO MORE ANESTHESIA. IT WAS ALSO CONFIRMED THAT THE CUT SUTURE WAS NOT FULLY RETRIEVED FROM THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 9693158 ↗