Arthrex® AR-8400CDCRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867043480), received between Nov 1, 2023 and Nov 6, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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. How this data works · Data updated Oct 13, 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.

• InjuryNov 6, 2023Material Fragmentation; Material Fragmentation

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8400CDC DOUBLECUT WAS RELEASING BLACK RESIDUE INTO THE JOIN. THE CASE WAS COMPLETED WITH ANOTHER AR-8400CDC DOUBLECUT FROM A DIFFERENT LOT NUMBER. THIS WAS DISCOVERED DURING AN ANKLE SCOPE PROCEDURE. THE BLACK RESIDUE WAS REMOVED FROM INSIDE THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 18075829 ↗
• MalfunctionNov 1, 2023Material Fragmentation; Material Fragmentation

  ON (B)(6) 2023 IT WAS REPORTED, BY A SALES REPRESENTATIVE VIA EMAIL, THAT AN AR-8400CDC DOUBLECUT WAS RELEASING BLACK RESIDUE INTO THE JOINT. THE CASE WAS COMPLETED WITH ANOTHER AR-8400CDC DOUBLECUT FROM A DIFFERENT LOT NUMBER. THIS WAS DISCOVERED DURING AN ANKLE SCOPE PROCEDURE. ADDITIONAL INFORMATION RECEIVED ON 10/06/2023: THE BLACK RESIDUE WAS REMOVED FROM INSIDE THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 18046322 ↗