Arthrex® AR-8380ECRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867043374), received between Jun 4, 2024 and Jun 4, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2024Break; Break

  (B)(6) 2021, IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS THAT AN AR-8380EC END CUTTER HEAD OF THE BLADE FELL APART. THIS WAS DISCOVERED DURING A ARTHROSCOPY MENISCECTOMY PROCEDURE ON (B)(4) 2021. SURGEON SWITCHED DEVICES AND WAS ABLE TO COMPLETE CASE WITHOUT FURTHER ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19457395 ↗