Arthrex® AR-8400CRERecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867043510), received between Feb 9, 2021 and Feb 8, 2023 — classified as 3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 8, 2023Break

  IT WAS REPORTED ON 01/23/2023 BY A ARTHREX EMPLOYEE VIA SEMS THAT AN AR-8400CRE BURR BROKE OFF IN THE JOINT CASE INVOLVEMENT, DEVICE BROKE DURING USE. WHILE SHAVING AN OSTEOPHYTE DURING OPE OF AN ANKLE JOINT, IT BROKE OFF FROM THE TIP. ALL DEBRIS WAS REMOVED. USED ANOTHER COMPANIES' PRODUCT AND THE CASE IS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16323666 ↗
• MalfunctionDec 13, 2021Break

  ON (B)(6) 2021, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA SEMS THAT AN AR-8400CRE BURR WAS DAMAGED AT THE CUTTING EDGE. THIS WAS DISCOVERED USE IN A FOOT JOINT REPAIR PROCEDURE WHEN THE SHAVER WAS USED ON CARTILAGE/TISSUE ON (B)(6) 2021. THE CASE WAS COMPLETED USING A NEW PRODUCT. REP CONTACTED (B)(6) TO CONFIRM WHETHER FRAGMENTS WERE PRODUCED/ENTERED PATIENT. UPDATE: REP RETURNED CONTACT (B)(6). CONFIRMED FRAGMENTS WERE PRODUCED AND ENTERED THE PATIENT. ALL DEBRIS WAS CONFIRMED REMOVED.

  Patient problems: Insufficient Information

  MAUDE report 12984010 ↗
• MalfunctionFeb 9, 2021Break

  IT WAS REPORTED THAT THE TIP OF THE INNER CYLINDER BROKE IMMEDIATELY AFTER THE FIRST USE. THE NUMBER OF ROTATIONS IS 3600 IN THE FORWARD ROTATION. THE SURGEON USED A NEW PRODUCT AND THE CASE IS COMPLETED WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11302002 ↗