Arthrex® AR-9223Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867059191), received between Jul 13, 2021 and Jul 13, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Reprocessing Problem” (2 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 13, 2021Device Reprocessing Problem

  IT WAS REPORTED, DURING THE 1ST DECONTAMINATION OF THE INSTRUMENT IT WAS NOTED THAT EVEN AFTER WASHING, BLOODY FLUID TRICKLED OUT FROM BETWEEN THE WHITE CAP AND THE METAL HANDLE. THIS INSTRUMENT IS USED AS AN INSERTER AND THEREFORE HAS PRESSURE APPLIED DURING ITS USE. IN EVALUATING THE DEVICE WE NOTED IN RECREATING PRESSURE, WE COULD OBSERVE BLOODY FLUID CONTINUE TO SEEP OUT FROM BETWEEN THE 2 PIECES. THE INSTRUMENT WAS SOAKED FOR SEVERAL MINUTES AND PRESSURE WAS REAPPLIED, WITH AGAIN THE SAME RESULTS. IN ATTEMPTS TO CLEAN IT WE SOAKED THE ITEM IN BLEACH FOR 30 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12163235 ↗
• MalfunctionJul 13, 2021Device Reprocessing Problem

  IT WAS REPORTED DURING STERILE PROCESSING, AS THE TECH PUSHED THE IMPACTOR DOWN ONTO THE TABLE, NOTICE LEAKAGE COMING OUT FROM THE WHITE PLASTIC TIP, WHERE THE METAL MEETS THE WHITE PLASTIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12163219 ↗
• MalfunctionJul 13, 2021Output Problem

  YESTERDAY WE DID 3 TOTAL SHOULDERS, DURING THE 1ST DECONTAMINATION OF THE INSTRUMENT IT WAS NOTED THAT EVEN AFTER WASHING, BLOODY FLUID TRICKLED OUT FROM BETWEEN THE WHITE CAP AND THE METAL HANDLE. THIS INSTRUMENT IS USED AS AN INSERTER AND THEREFORE HAS PRESSURE APPLIED DURING ITS USE. IN EVALUATING THE DEVICE WE NOTED IN RECREATING PRESSURE, WE COULD OBSERVE BLOODY FLUID CONTINUE TO SEEP OUT FROM BETWEEN THE 2 PIECES. THE INSTRUMENT WAS SOAKED FOR SEVERAL MINUTES AND PRESSURE WAS REAPPLIED, WITH AGAIN THE SAME RESULTS. IN ATTEMPTS TO CLEAN IT WE SOAKED THE ITEM IN BLEACH FOR 30 MINUTES.

  Patient problems: Insufficient Information

  MAUDE report 12158792 ↗