Arthrex® AR-3350-2430Recalls & reported problems
Arthrex, Inc. · ARTHROSCOPE, 30 DEG, 2.4 X 72MM · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867029545), received between Mar 12, 2021 and Jul 18, 2023 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (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
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Break1
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Unspecified Infection2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 18, 2023Scratched Material; Scratched Material
ON 06/13/2023, IT WAS REPORTED BY A ARTHREX EMPLOYEE VIA SEMS THAT AN AR-3350-2430 SCOPE LENS IS SCRATCHED. THIS WAS DISCOVERED DURING AN UNSPECIFIED TIME WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17343698 ↗MalfunctionDec 27, 2022Break
IT WAS REPORTED THAT THE DEVICE BROKE OFF AT THE JOINT DURING SURGERY. THE BROKEN PIECES WERE RETRIEVED FROM PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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: No Clinical Signs, Symptoms or Conditions
MAUDE report 16051084 ↗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 11475497 ↗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 11475484 ↗
Other ARTHROSCOPE devices
- FMS 283512Medos International Sàrl · ARTHROSCOPE1,800 reports
- Arthrex® AR-6480Arthrex, Inc. · ARTHROSCOPE949 reports
- FMS VUE 284002Depuy Mitek, LLC · ARTHROSCOPE829 reports
- MITEK 242018Medos International Sàrl · Arthroscope731 reports
- METRx® System 9560100Medtronic Sofamor Danek, Inc. · Arthroscope667 reports
- FMS VUE II 284004Medos International Sàrl · Arthroscope562 reports
- VAPR COOLPULSE 228146Depuy Mitek, LLC · ARTHROSCOPE474 reports
- FMS DUO 284580Depuy Mitek, LLC · ARTHROSCOPE458 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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