Arthrex® AR-300-406SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888867028446), received between Nov 15, 2024 and Nov 15, 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• MalfunctionNov 15, 2024Break; Break

  ON 09/02/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-400 DRILLSAW SPORTS 400 SYSTEM DETACHED. THIS OCCURRED DURING A CASE. THERE WAS NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION WAS PROVIDED ON 10/07/2024 WHERE IT WAS STATED THAT THIS EVENT OCCURRED DURING A CRUCIATE LIGAMENT PROCEDURE WHEN THE DEVICE BROKE AT THE TIME OF BEING ACTUATED. AN AR-300-406S SAW BLADE WAS BEING USED. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. A CINSEL AND HAMMER WERE USED TO COMPLETE THE CASE. THERE WAS NO ADDITIONAL ANESTHESIA ADMINISTERED.

  Patient problems: Insufficient Information

  MAUDE report 20698138 ↗