Arthrex® AR-8400CSSRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867043534), received between Nov 15, 2018 and Oct 31, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Connection Problem” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 31, 2022Connection Problem; Unintended Movement; Unintended Movement

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-8400CSS BURR TIP DISENGAGED. THIS OCCURRED ON (B)(6) 2022 DURING A LABRAL REPAIR WHILE THE SURGEON WAS ON FORWARD/REVERSE WHILE CREATING A BLEEDING BONE SURFACE THE SLAP BURR TIP DISENGAGED. THERE WAS NO PATIENT EFFECT REPORTED, AND NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15698385 ↗
• InjuryNov 15, 2018Material Fragmentation

  IT WAS REPORTED DURING THE ROTATOR CUFF THE BURR STARTED TO PRODUCE MEDAL SHAVINGS. SOME OF THE DEBRIS WAS VERY SMALL AND NOT ALL HAVE BEEN RETRIEVED. THE DOCTOR WAS DONE SHAVING WHEN THE DEBRIS WAS DISCOVERED. HE DID NOT HAVE TO REPLACE IT TO CONTINUE AND THE CASE WAS COMPLETED WITH NO FURTHER ISSUES. THE REP WAS NOT IN THE CASE AND ALSO MADE THE STATEMENT AN X-RAY WAS NOT TAKEN TO CONFIRM THE SHAVINGS.

  Patient problems: No Code Available

  MAUDE report 8074699 ↗