Arthrex® AR-1915FT-2-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867280755), received between Dec 27, 2021 and Nov 20, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 20, 2024Break; Break

  IT WAS REPORTED THAT DURING A RECONSTRUCTION OF RADIAL CAPSULAR LIGAMENT SURGERY THE ANCHOR BROKE. THE DEVICE DID NOT BREAK INSIDE THE PATIENT. PER COMPLAINT REPORTER 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 20735986 ↗
• MalfunctionAug 31, 2023Break; Break

  IT WAS REPORTED THAT DURING ROTATOR CUFF SURGERY THE SCREW BROKE OFF WHEN BEING SCREWED INSIDE THE PATIENT. THE BROKEN PIECES WERE RETRIEVED FROM PATIENT. 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 17662463 ↗
• MalfunctionMar 7, 2022Break

  IT WAS REPORTED THAT DURING A SURGERY ACCORDING TO HOHMANN AND RECONSTRUCTION OF THE RADIAL CAPSULAR LIGAMENT ATTACHMENT THE DEVICE BROKE DURING INSERTION. THE SURGEON TRIED TO RETRIEVE THE INTRABONY PART OF THE ANCHOR, BUT THAT WAS NOT POSSIBLE AND THE BROKEN PART REMAINED INSIDE THE PATIENT. A SECOND DEVICE WAS PLACED BESIDE THE BROKEN ANCHOR. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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 13684873 ↗
• MalfunctionDec 27, 2021Defective Component

  IT WAS REPORTED THAT DURING A SURGERY THE HANDLE OF THE DEVICE WAS BROKEN. NO PART OF THE DEVICE BROKE OFF. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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. UPDATE 10-DEC-2021: IT WAS CONFIRMED THAT AT FIRST THE WRONG INFORMATION WAS PROVIDED WITH THE COMPLAINT. THE ANCHOR BROKE DURING INSERTION. PART OF THE ANCHOR BROKE OFF DURING INSERTED INTO THE PATIENT. THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13087830 ↗