Arthrex® AR-8400CBCRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867043473), received between Oct 4, 2021 and Dec 18, 2025 — 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. How this data works · Data updated Oct 13, 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.

• MalfunctionDec 18, 2025Break; Material Fragmentation; Break; Material Fragmentation

  ON 11/28/2025, AN FDA MEDSUN NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT TWO AR-8400CBC BONE CUTTERS BROKE DURING USE ON A PATIENT¿S ANKLE, RESULTING IN METALLIC DEBRIS WITHIN THE SURGICAL SITE. ACCORDING TO THE OPERATIVE REPORT, ALL METALLIC DEBRIS WAS RETRIEVED ARTHROSCOPICALLY. THE SURGEON NOTED THAT BOTH DEVICES MALFUNCTIONED AND FAILED TO FUNCTION AS INTENDED. THE PROCEDURE WAS COMPLETED USING AN ANGLED CURETTE FROM THE BONE SET. THIS INCIDENT OCCURRED DURING A LEFT ANKLE ARTHROSCOPY WITH DEBRIDEMENT AND MICROFRACTURE OF A MEDIAL TALUS OSTEOCHONDRAL DEFECT PROCEDURE IN (B)(6) 2025.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23837740 ↗
• MalfunctionDec 18, 2025Break; Material Fragmentation; Break; Material Fragmentation

  ADDITIONAL INFORMATION WAS RECEIVED ON 30-JAN-2026: DURING A PROCEDURE ON (B)(6) 2025, TWO AR-8400CBC BONE CUTTERS REPORTEDLY BROKE WHILE CUTTING. THE SURGERY WAS NOT DELAYED, NO ADDITIONAL ANESTHESIA WAS REQUIRED, AND NO ADVERSE EFFECTS WERE REPORTED. NO ADDITIONAL SURGICAL INTERVENTION WAS NEEDED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23837635 ↗
• MalfunctionNov 28, 2025Break

  FROM STAFF: PATIENT WAS HAVING AN ANKLE ARTHROSCOPY. ARTHREX 4.0 CURVED BONE CUTTER, AR8400CBC BROKE X 2 WHILE USING IN THE PATIENT'S ANKLE. SURGEON STATES THAT HE GOT ALL METAL SHARDS OUT. FROM OPERATIVE REPORT: I MADE SEVERAL ATTEMPTS TO REMOVE THIS WITH ARTHROSCOPIC SHAVERS, INCLUDING CHANGING SHAVER SIZE AND USING A CURVED SHAVER. ACTUALLY 2 OF THE CURVED SHAVERS ACTUALLY BROKE AND THERE WAS SOME METALLIC DEBRIS IN THE AREA, WHICH WAS REMOVED ARTHROSCOPICALLY. ALL OF THE METAL DEBRIS WAS REMOVED. I WAS FINALLY ABLE TO FIND SOMETHING THAT WOULD REMOVE THE OSTEOCHONDRAL DEFECT, WHICH ACTUALLY TURNED OUT TO BE AN ANGLE CURETTE FROM THE BONE SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23671341 ↗
• MalfunctionOct 4, 2021Material Integrity Problem

  ON (B)(6) 2021 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8400CBC BONE CUTTER LEFT METAL DEBRIS ON THE LEFT SIDE AREA WHERE SURGEON WAS WORKING ON. THIS WAS DISCOVERED DURING AN RCR PROCEDURE. SURGEON USED A NEW BONE CUTTER TO COMPLETE CASE SUCCESSFULLY, NO PATIENT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12571021 ↗