Arthrex® AR-3351-1030Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888867029729), received between Jun 5, 2024 and Jun 20, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Defective Device” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 20, 2024Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT THE DEVICE IS SHARP-EDGED AT THE DISTAL END. THE PROBLEM WAS NOTICED BY REPROCESSING. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19574888 ↗
• MalfunctionJun 18, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE DEVICE IS SHARP-EDGED IN FRONT (TRANSITION FROM METAL TO LIGHT GUIDE). THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19558994 ↗
• MalfunctionJun 18, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE DISTAL END OF THIS OPTIC IS SHARP EDGED. THERE WAS NO HARM FOR THE PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19558594 ↗
• MalfunctionJun 10, 2024Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT THE DEVICE IS SHARP-EDGED AND CLOUDY. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19503383 ↗
• MalfunctionJun 10, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT THE FRONT OF THE OPTIC IS TOO SHARP. NO ADDITIONAL INFORMATION REGARDING A SPECIFIC FAILURE MODE WAS PROVIDED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19499091 ↗
• MalfunctionJun 7, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT THE OPTICS IS SHARP-EDGED. THERE WAS NO HARM FOR THE PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19483762 ↗
• MalfunctionJun 5, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT THE TIP OF THE OPTICS IS VERY SHARP. THERE WAS NO HARM FOR THE PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 19472637 ↗