Arthrex® AR-1915FT-2Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867022621), received between Nov 8, 2023 and Mar 26, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2026Break

  IT WAS REPORTED THAT DURING A SURGERY, THE TIP OF THE ANCHOR BROKE OFF. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE WAS USED ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24699735 ↗
• MalfunctionDec 31, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  ON (B)(6) 2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-1915FT-2 CORKSCREW'S SUTURES WERE CUT WHEN THE KNOTS WERE TIED. THIS WAS DISCOVERED DURING USE WITH NO FURTHER INFORMATION PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23934510 ↗
• MalfunctionDec 9, 2025Break; Break

  ON (B)(6) 2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-1915FT-2 CORKSCREW ANCHOR BROKE, LEAVING HALF INSIDE THE PATIENT AND THE SUTURES. THIS WAS DISCOVERED DURING USE WITH NO PATIENT HARM.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23757602 ↗
• MalfunctionJun 18, 2025Break; Break

  ON 05/23/2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA (B)(4). THAT AN AR-1915FT-2 SUTURE ANCHOR CORKSCREW FT ANCHOR BROKE. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22282616 ↗
• MalfunctionNov 8, 2023Break; Break

  IT WAS REPORTED THAT DURING A FOOT SURGERY WITH ONE ANCHOR THE SCREW BROKE OFF INSIDE THE PATIENT AND WAS RETRIEVED. WITH THE SECOND ANCHOR THE THREAD DID NOT RELEASE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18093769 ↗