Arthrex® AR-3350-2930Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867029583), received between Nov 16, 2016 and Mar 9, 2023 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Poor Quality Image” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMar 9, 2023No Display/Image; Defective Device; No Display/Image; Defective Device

  ON (B)(6) 2023 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-3350-2930 SCOPE VIEW IS OBSTRUCTED. THIS WAS DISCOVERED DURING AN ENDOSCOPIC CARPAL TUNNEL RELEASE AND WAS RESOLVED BY USING AN OPEN PROCEDURE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information

  MAUDE report 16511665 ↗
• InjurySep 7, 2021Material Opacification

  IT WAS REPORTED ON (B)(6) 2021 DURING A PROCEDURE, THE ARTHROSCOPE, AR-3350-2930, WAS FOUND TO BE CLOUDY. A BACKUP SCOPE WAS NOT AVAILABLE AND THE SURGEON CONVERTED TO AN OPEN PROCEDURE TO COMPLETE THE CASE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 12434700 ↗
• InjuryNov 26, 2019Product Quality Problem

  IT WAS REPORTED DURING AN ENDOSCOPIC CARPAL TUNNEL PROCEDURE AS THE SURGEON WENT TO USE THE AR-3350-2930, C-LINE CARPAL TUNNEL SCOPE THE VIEW THROUGH THE LENS WAS VERY BLURRY AND THE SCOPE WOULD NOT FOCUS. A REPLACEMENT SCOPE WAS NOT BROUGHT IN. THE SURGEON THEN SWITCHED FROM AN ARTHROSCOPIC TO AN OPEN PROCEDURE BY MAKING A LARGER INCISION.

  Patient problems: No Code Available

  MAUDE report 9376543 ↗
• InjuryJun 26, 2019Poor Quality Image

  IT WAS REPORTED THAT AT THE START OF A PROCEDURE, THE SURGEON COULD NOT SEE EASILY THROUGH THE ARTHROSCOPE, AR-3350-2930. THE SCOPE WAS FOGGY, AND THE STAFF IN THE OR COULD NOT FIX IT. AFTER STRUGGLING FOR A FEW MINUTES WITH THE SCOPE, THE SURGEON DECIDED TO DO THE SPECIFIC PROCEDURE OPEN, AS THE SCOPE WAS UNUSABLE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8735880 ↗
• MalfunctionOct 4, 2017Poor Quality Image

  IT WAS REPORTED THAT THE DEVICE HAS A SHADE INSIDE THE SIGHT. BECAUSE OF THE BAD SIGHT THE SURGEON NEEDED TO CHANGE THE TECHNIQUE FROM AN ENDOSCOPIC CTS- SURGERY TO A OPEN CTS-SURGERY.

  Patient problems: No Code Available

  MAUDE report 6913255 ↗
• InjuryNov 16, 2016Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT DURING A CARPEL TUNNEL ARTHROSCOPY, THE THICKER PART OF THE SCOPE SHAFT WAS TOO LONG AND THE SURGEON COULD NOT ATTACH THE DISPOSABLE PIECE ((B)(4)) ON IT. REP OBTAINED ANOTHER SCOPE AND SUBMITTED IT FOR STERILIZATION BUT SURGEON CHOSE NOT TO WAIT FOR THE ADDITIONAL SCOPE AND PROCEEDED INSTEAD WITH AN OPEN PROCEDURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6105404 ↗