Arthrex® AR-1204AS-70Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867004399), received between May 9, 2022 and Nov 5, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 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.

• MalfunctionNov 5, 2025Break; Break

  IT WAS REPORTED DURING THE ALL INSIDE ANTERIOR CRUCIATE LIGAMENT SURGERY THAT THE DEVICE BROKE WHEN RETRACTED AND SPLIT INTO TWO PIECES. 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. ON (B)(6) 2025 MAJUNG: FURTHER INFORMATION WAS RECEIVED BY THE SALES REP: THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23478208 ↗
• MalfunctionMay 9, 2022Break

  IT WAS REPORTED THAT DURING A SURGERY THE MOVABLE BLADE BROKE OFF IN THE JOINT. IT WAS FURTHER REPORTED THAT IT WAS IMPOSSIBLE TO REMOVE THE INSTRUMENT. NO FURTHER INFORMATION RECEIVED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 14336489 ↗