Arthrex® AR-3351-1000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867029705), received between Jan 31, 2022 and Jan 25, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fire” (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. 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.

• MalfunctionJan 25, 2024Material Fragmentation; Sharp Edges; Material Fragmentation; Sharp Edges

  UPDATE DW 30-JAN-2024: FURTHER INFORMATION WERE PROVIDED THAT THE REPORTED EVENT OCCURRED DURING A MINIMAL INVASIVE HERNIA SURGERY. SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITHOUT FURTHER ISSUES. IT WAS FURTHER REPORTED THAT DUE TO THE SHARP END A BALLOON WAS DAMAGED BUT NO PLASTIC DEBRIS WAS INTRODUCED INTO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18580222 ↗
• MalfunctionJan 31, 2022Fire

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(6) THAT DURING A PROCEDURE AN AR-3351-1000 ARTHROSCOPE WAS CONNECTED AND LIGHT ENGINE ON WHILE SITTING ON A DRAPE. THE ARTHROSCOPE WHILE SITTING ON THE DRAPE CAUSED A FIRE. NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED 1/18/2022 BY A SALES REPRESENTATIVE VIA PHONE THAT NO PATIENT WAS HARMED AND THE CASE WAS COMPLETED BY USING THE SAME DEVICE. THE SALES REPRESENTATIVE WAS NOT PRESENT DURING THIS CASE AND UPON ARRIVAL ON THE (B)(6) 2022, WAS ADVISED BY THE FACILITY THAT THE DEVICE WAS STERILIZED AND PLACED BACK INTO CIRCULATION. THE SERIAL NUMBER WAS NOT CAPTURED AND WILL NOT BE RETURNING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13397283 ↗