Arthrex® AR-3350-4030Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00888867029637), received between Jan 27, 2020 and Dec 23, 2025 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Break” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 23, 2025Sharp Edges; Sharp Edges

  ON 12/2/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS (B)(4) THAT AN AR-3350-4030 SCOPE HAS A SHARP PIECE ON THE SIDE OF THE LENS. NOTICED DURING A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23878116 ↗
• MalfunctionJun 11, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING THE MENISCAL RESECTION SURGERY THE METAL SCOPE PART IS MOVING AND THE LIGHT IS GETTING THROUGH THE SCOPE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY 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. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19509448 ↗
• MalfunctionJun 7, 2024Break; Break

  ON 06/28/2022, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT A AR-3350-4030 ARTHROSCOPES BLACK EYE PIECE IS COMING APART. THIS WAS DISCOVERED DURING AN UNKNOWN CASE, WITH NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19487701 ↗
• MalfunctionJun 7, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE DEVICE HAS A SHARP EDGE. 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 19484647 ↗
• MalfunctionJun 4, 2024Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT THE DISTAL END IS SHARP. 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 19457215 ↗
• MalfunctionApr 26, 2024Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS (B)(4) THAT AN AR-3350-4030 SCOPE MOUNT HAS BROKEN OFF. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19192180 ↗
• MalfunctionMar 12, 2021Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE FOLLOWING DEVICES WERE PRESENT DURING A PROCEDURE,AR-3350-2430, AR-3350-4030, AR-3210-0001, AR-8330F, WERE A PATIENT GOT AN INFECTION. IT WAS FOUND THAT THE INFECTION IS NOT DUE TO ARTHREX PRODUCT(S), HOWEVER, CUSTOMER WOULD LIKE TO CHANGE ALL THEIR PRODUCTS THAT WERE USED DURING THIS PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 11475243 ↗
• MalfunctionMar 12, 2021Microbial Contamination of Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE FOLLOWING DEVICES WERE PRESENT DURING A PROCEDURE,AR-3350-2430, AR-3350-4030, AR-3210-0001, AR-8330F, WERE A PATIENT GOT AN INFECTION. IT WAS FOUND THAT THE INFECTION IS NOT DUE TO ARTHREX PRODUCT(S), HOWEVER, CUSTOMER WOULD LIKE TO CHANGE ALL THEIR PRODUCTS THAT WERE USED DURING THIS PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 11475206 ↗
• InjuryJan 27, 2020Display Difficult to Read

  IT WAS REPORTED THAT THE 30 DEGREE HD ARTHROSCOPE, AR-3350-4030, WAS BEING USED DURING A PROCEDURE. DURING THE SURGERY, THE VIEW THROUGH THE ARTHROSCOPE WAS VERY VAGUE AND THE SURGEON WAS UNABLE TO SEE THE STRUCTURE OF THE PATIENT'S TISSUE CLEARLY. AS NO OTHER ARTHROSCOPE WAS AVAILABLE FOR THE PROCEDURE, THE SURGEON HAD TO TERMINATE THE SURGERY AND RESCHEDULE FOR ANOTHER DAY AFTER SPEAKING WITH THE PATIENT AND THEIR FAMILY. THE ARTHROSCOPE WAS SENT TO A THIRD PARTY FOR REPAIR AND WILL NOT BE RETURNED AS IT IS NO LONGER IN THE CONDITION IT WAS AT THE TIME OF THE INCIDENT DETAILED ABOVE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9631793 ↗