Arthrex® AR-3350-4031Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00888867291690), received between Jul 6, 2023 and Feb 18, 2025 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 18, 2025No Display/Image; Display or Visual Feedback Problem; No Display/Image; Display or Visual Feedback Problem

  NO COMPLAINT ALLEGATION WAS PROVIDED. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION WAS RECEIVED. UPDATE DW 12-FEB-2025: FURTHER INFORMATION WAS PROVIDED THAT DURING A SURGERY IT WAS FOUND THAT NOTHING COULD BE SEEN THROUGH THE USED OPTIC. AS NO REPLACEMENT DEVICE WAS AVAILABLE THE CUSTOMER HAD TO ABORT THE SURGERY AND THE PATIENT HAD TO BE AWAKENED. UPDATE DW 13-FEB-2025: IT WAS FURTHER REPORTED THAT THE REPORTED DEVICE STOPPED WORKING DURING A KNEE SURGERY ON THE MENISCUS. IT IS NOT KNOWN IF THE PATIENT RECEIVED AN ADDITIONAL TREATMENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21396586 ↗
• MalfunctionFeb 18, 2025Sharp Edges; Sharp Edges

  ON 01/31/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3350-4031 SCOPE HAS SHARP METAL PIECE ON THE DISTAL TIP. DISCOVERED DURING A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21393378 ↗
• MalfunctionSep 6, 2024Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC KNEE SURGERY A RUBBER STRIP HAS COME OFF THE OCULAR AND ALWAYS PRODUCED A BLACK STRIPE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20155904 ↗
• InjuryJul 17, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A SURGERY THE SCOPE, LIGHT CABLE OR BOTH OVER HEATED AND BURNED THE PATIENTS LEG. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Burn(s)

  MAUDE report 19760717 ↗
• MalfunctionJun 7, 2024Break; Break

  IT WAS REPORTED ON 05/04/2022 BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-3350-4031 SCOPES BLACK EYEPIECE FELL OFF. THIS WAS DISCOVERED DURING AN UNSPECIFIED TIME WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19488955 ↗
• MalfunctionJun 7, 2024Break; Break

  ON 01/16/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-3350-4031 SCOPE AND AN AR-3350-4071 SCOPE BOTH HAVE A DETACHED BLACK EYE PIECE. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE, WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19486910 ↗
• MalfunctionJun 6, 2024Break; Break

  IT WAS REPORTED ON 1/11/2022 BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-3350-4031 SCOPE IS FALLING APART "GLUE IS COMING LOOSE". THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19475385 ↗
• MalfunctionJan 26, 2024Crack; Crack

  ON 01/17/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-3350-4031 SCOPE BASE IS CRACKED AND DIFFICULT TO STAY ATTACHED TO CAMERA. THIS OCCURRED DURING AN ARTHROSCOPIC PROCEDURE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18587430 ↗
• MalfunctionNov 27, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 11/6/2023, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS-06392638 THAT AN AR-3350-4031 ARTHROSCOPE CAME APART DURING SURGERY. THE EYEPIECE DETACHED ITSELF FROM THE SCOPE. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18209574 ↗
• MalfunctionJul 13, 2023Leak/Splash; Leak/Splash

  ON (B)(6) 2023, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-3350-4031 ARTHROSCOPE IS EXPERIENCING WATER INVASION, IT IS FILLING UP THE BOTTOM PORTION OF THE LENS. THIS OCCURRED DURING A CASE, WITH NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17314952 ↗
• MalfunctionJul 6, 2023Break; Break

  ON 6/15/2023, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-3350-4031 4K ARTHROSCOPE LENS WAS CRACKED AND NOT GIVING A CLEAR IMAGE. THE CASE WAS COMPLETED BY SWITCHING OUT THE SCOPE FOR ANOTHER. THIS WAS DISCOVERED DURING AN ARTHROSCOPY PROCEDURE, WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17272927 ↗