Arthrex® AR-8400CSTRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867043541), received between Aug 4, 2016 and Aug 4, 2016 — classified as 1 injury.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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.

• InjuryAug 4, 2016Device Operates Differently Than Expected

  IT WAS REPORTED THAT TWO 4.0MM CURVED SABRETOOTH BURRS WERE BEING USED IN A SHOULDER ARTHROSCOPY PROCEDURE. THE FIRST SABRETOOTH BURR WAS PRODUCING SHAVINGS WHEN SURGEON WAS SHAVING CUFF TISSUE AS WELL AS A BONY DEFECT ON THE GLENOID. THE SECOND SABRETOOTH BURR WAS OPENED, AND WAS HAVING THE SAME ISSUES AS THE FIRST ONE. FOR BOTH OF THESE BURRS, THEY WERE RUNNING THE SHAVER AT 2500RPM'S AND IN AGGRESSIVE MODE. THE SHAVINGS WERE REMOVED BY THE SHAVER AND SUCTION, BUT SOME DEBRIS STILL REMAINS IN THE PATIENT'S SOFT TISSUE SINCE THEY WERE TOO SMALL TO RETRIEVE. THE SURGEON SWITCHED TO USING A 4.0 BONE CUTTER TO COMPLETE THE PROCEDURE SUCCESSFULLY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 5846281 ↗