Arthrex® AR-8380EXRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867043381), received between Jul 23, 2019 and Mar 15, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Entrapment of Device” (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.

• MalfunctionMar 15, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A MENISCUS REFIXATION SURGERY IT WAS NOTICED THAT THE SHRINK TUBING ON THE BLADE IS IRREPARABLY DAMAGED. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18914148 ↗
• InjuryJul 23, 2019Entrapment of Device; Material Fragmentation

  IT WAS REPORTED THAT DURING A PROCEDURE, THE EXCALIBUR BLADE, AR-8380EX, WAS CONNECTED TO THE HANDPIECE AND INSERTED INTO THE JOINT AS NORMAL. THE SURGEON ACTIVATED THE SHAVER IN OSC MODE (WITHOUT MAKING CONTACT WITH ANY SOFT TISSUE OR BONE AND METALS SHARDS APPEARED). THE METAL FRAGMENTS FELL INTO THE PATIENT'S BODY. ANOTHER BLADE WAS OPENED TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED 7/5/19: THIS OCCURRED DURING TISSUE DEBRIDEMENT DURING AN ANKLE ARTHROSCOPY. SUCTION WAS USED TO REMOVE METALS SHAVINGS. REP IS NOT 100% CERTAIN THAT ALL FRAGMENTS WERE REMOVED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8817445 ↗