Arthrex® AR-3370-0001Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867029880), received between Mar 8, 2021 and Mar 8, 2021 — classified as 2 malfunctions.

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

• MalfunctionMar 8, 2021Material Fragmentation

  IT WAS REPORTED THAT THE SURGEON FOUNT SOMETHING THAT MAY LOOK LIKE SMALL RED PIECES OF PLASTIC IN THE KNEE JOINT DURING KNEE ARTHROSCOPY. THEY HAVE EXAMINED EVERYTHING, THE ONLY RED IS THE RED GASKET OF AR-3370-0001. THE PIECES WERE REMOVED FROM PATIENT. NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY WAS REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE WAS USED ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11436051 ↗
• MalfunctionMar 8, 2021Material Fragmentation

  IT WAS REPORTED THAT THE SURGEON FOUNT SOMETHING THAT MAY LOOK LIKE SMALL RED PIECES OF PLASTIC IN THE KNEE JOINT DURING KNEE ARTHROSCOPY. THEY HAVE EXAMINED EVERYTHING, THE ONLY RED IS THE RED GASKET OF AR-3370-0001. THE PIECES WERE REMOVED FROM PATIENT. NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY WAS REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE WAS USED ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11436034 ↗