Arthrex® AR-1204AS-60Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867004375), received between Aug 16, 2023 and May 22, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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.

• MalfunctionMay 22, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED ON 04/04/2023 BY A ARTHREX EMPLOYEE VIA (B)(4) THAT AN AR-1204AS-60 FLIPCUTTER AFTER CREATING THE SOCKET, THE AR-1204AS-60 AND THE HOLLOW DRILL (DRILL GUIDE) GOT STUCK AND COULD NOT BE REMOVED. NO PATIENT HARMS. CASE INVOLVEMENT, NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19373424 ↗
• MalfunctionAug 16, 2023Unintended Movement; Unintended Movement

  ON (B)(6) 2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA SEMS THAT AN AR-1204AS-60 FLIPCUTTER II HAD AN ISSUE. THE FIXATION OF THE BLADE WAS NOT STABLE AFTER FLIPPING. THE CASE WAS COMPLETED USING A NEW PRODUCT. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE ON (B)(6) 2023, WITH NO PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2023: THIS WAS DISCOVERED DURING AN ACL REPAIR PROCEDURE WITH NO REPORTED DELAY IN THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17559371 ↗