Arthrex® AR-1204F-24IRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867004528), received between May 10, 2021 and May 10, 2021 — classified as 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 10, 2021Break

  IT WAS REPORTED THAT THE 2.4 MM RING OF THE DEVICE DETACHED FROM THE SLEEVE AND BROKE OFF DURING AN ARTHROSCOPY SURGERY. NO PART BROKE INSIDE THE PATIENT. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. 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 29-APR-2021: IT WAS CONFIRMED THAT THE RING OF THE DEVICE BROKE OF DURING PULLING OUT WHILE THE SURGEON WAS WORKING WITH THE DEVICE IN THE PATIENT. THERE WAS NO HARM FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11798494 ↗