Arthrex® AR-3210-0031Recalls & reported problems
Arthrex, Inc. · 4K SynergyUHD4 Ultra, Autoclavable · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00888867279315), received between Feb 28, 2022 and Jul 28, 2025 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Display or Visual Feedback Problem” (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.
Reports received per month
Most reported problems
Device problems
- Display or Visual Feedback Problem4
- Overheating of Device4
- Image Display Error/Artifact2
- Misfocusing2
- Electrical Shorting1
- Output Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions9
- Insufficient Information1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 28, 2025Overheating of Device; Overheating of Device
IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SURGERY THE CAMERA HEAD HEATED UP. PER COMPLAINT REPORTER 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 22637905 ↗MalfunctionApr 8, 2024Overheating of Device; Overheating of Device
IT WAS REPORTED ON 08/03/2022 BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-3210-0031 CAMERA IS OVERHEATING. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19065664 ↗MalfunctionMar 8, 2024Electrical Shorting; Electrical Shorting
ON 02/26/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3210-0031 CAMERA APPEARED TO HAVE A SHORT IN IT. NO CASE INVOLVEMENT.
Patient problems: Insufficient Information
MAUDE report 18869743 ↗MalfunctionFeb 7, 2024Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE DEVICE OVERHEATS UNCONVENTIONALLY, SO THAT WORKING WITH THE DEVICE IS NOT POSSIBLE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED. UPDATE AVOE (B)(6) 2022 IT WAS CONFIRMED THAT THE ERROR OCCURRED DURING AN ARTHROSCOPIC TREATMENT OF TENDON RUPTURE OF THE SHOULDER, WHICH TOOK APPROX. 1.5 TO 2 H. THE USER COULD HARDLY HOLD THE DEVICE IN HIS HAND DUE TO THE HEAT DEVELOPMENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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 18661361 ↗MalfunctionJul 13, 2023Display or Visual Feedback Problem; Misfocusing; Display or Visual Feedback Problem; Misfocusing
ON 6/22/2023, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-3210-0031 CAMERA HEAD WOULD NOT FOCUS DURING SURGERY. THE CASE WAS COMPLETED WITH THE SAME CAMERA. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE, WITH NO ADVERSE EVENT OR PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17320678 ↗MalfunctionJul 13, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem
ON (B)(6) 2023, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-3210-0031 CAMERA IS SHOWING LINES ON THE MONITOR. THIS WAS DISCOVERED DURING A PROCEDURE. THE CASE WAS COMPLETED BY USING A NEW CAMERA WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17317553 ↗MalfunctionJul 13, 2023Misfocusing; Misfocusing
ON 06/19/2023, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-3210-0031 CAMERA HEAD WOULD LOSE FOCUS. THIS OCCURRED DURING A CASE, THE CASE WAS COMPLETED USING THE CAMERA. THERE WAS NO PATIENT EFFECT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17317542 ↗MalfunctionJul 13, 2023Display or Visual Feedback Problem; Image Display Error/Artifact; Display or Visual Feedback Problem; Image Display Error/Artifact
ON 06/14/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-3210-0031 CAMERA IMAGE IS BLURRY. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17315341 ↗MalfunctionJul 13, 2023Display or Visual Feedback Problem; Image Display Error/Artifact; Display or Visual Feedback Problem; Image Display Error/Artifact
ON 06/14/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-3210-0031 CAMERA IMAGE IS BLURRY. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17315323 ↗MalfunctionFeb 28, 2022Overheating of Device; Output Problem
ON (B)(6) 2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-3200-0021 SYNERGY CONSOLE WAS INVOLVED IN A CASE WHEN THE DRAPE WAS BURNT. NO ADDITIONAL INFORMATION AVAILABLE - UNSURE OF OTHER EQUIPMENT, EVERYTHING WAS RE-PROCESSED AND PUT BACK INTO CIRCULATION. ADDITIONAL INFORMATION: DURING A SHOULDER REPAIR THE LIGHT SWITCH AUTO WAS SWITCHED TO ON AND THE CAMERA WAS SITTING ON A MAYO STAND PRIOR TO THE CASE. THE DRAPE ON THE STAND HEATED UP AND A BURN WAS VISIBLE. THE CAMERA HEAD INVOLVED WAS AN AR-3210-0031. THERE WAS NO PATIENT INJURY. THE EQUIPMENT WAS TRADED OUT AND REPLACED THEN THE CASE WAS COMPLETED SUCCESSFULLY WITH NO FURTHER ISSUES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13620585 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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