Arthrex® AR-3210-0001Recalls & reported problems
Arthrex, Inc. · HEAD, 3CCD, ARTHREX SYNERGY HD3, ROHS · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867029309), received between Mar 12, 2021 and May 10, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Scratched Material1
Patient problems
- Unspecified Infection2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 10, 2024Scratched Material; Scratched Material
IT WAS REPORTED ON 02/28/2022 BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-3210-0001 CAMERA HAS A BURN MARK. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19288038 ↗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 11475276 ↗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 11475234 ↗
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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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