Arthrex® AR-3210-0043Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00888867375574), received between Aug 18, 2023 and Feb 11, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 11, 2025Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, WHEN THE MONOPOLAREN ABLATOR WAS USED, THE BUTTONS OF THE NANO NEEDLE WERE TRIGGERED. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE DW 29-JAN-2025: FURTHER INFORMATION WAS PROVIDED THAT EVERY TIME AN ABLATOR FROM ANOTHER MANUFACTURER WAS USED, THE FUNCTIONS ASSOCIATED WITH PRESSING A BUTTON WERE TRIGGERED UNCONTROLLABLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21354587 ↗
• MalfunctionSep 3, 2024Poor Quality Image; Poor Quality Image

  ON 08/08/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA SEMS(B)(4) THAT AN AR-3210-0043 NANOSCOPE NEEDLE BECAME BLURRED AFTER REPEATED INSERTION AND REMOVAL. THIS WAS DISCOVERED DURING A CASE. THIS CASE WAS COMPLETED BY NEW PRODUCT OF SAME PRODUCT NUMBER. NO PATIENT HARMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20127187 ↗
• MalfunctionJun 15, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  ON 05/01/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-3210-0043 NANONEEDLE FAILED WHEN WENT TO CALIBRATE CAMERA, IT WOULD NOT WHITE BALANCE. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19544084 ↗
• MalfunctionJun 14, 2024Failure to Calibrate; Failure to Calibrate

  ON 2/6/2023 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-3210-0043 NANONEEDLE WAS DISPLAYING AN ERROR MESSAGE. THE ERROR MESSAGE HAD A RED X ON THE CONSOLE AND SAID "UNABLE TO CALIBRATE. TRY AGAIN." THIS WAS DISCOVERED DURING A PROCEDURE AND WAS COMPLETED WITH ANOTHER NANONEEDLE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19540594 ↗
• MalfunctionJun 4, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A WRIST ARTHROSCOPY THERE WERE GROOVES AT THE LOWER END OF THE DEVICE. 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 19463978 ↗
• MalfunctionMay 21, 2024Defective Device; Defective Device

  ON 04/24/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3210-0043 NANONEEDLE SCOPES LIGHT SOURCE DID NOT WORK. THIS OCCURRED DURING A CASE ON 04/17/2024.

  Patient problems: Insufficient Information

  MAUDE report 19367132 ↗
• MalfunctionOct 12, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING A DEMO PERONEUS RECON SURGERY OF THE NANONEEDLE AN IMAGE SCATTERING IN THE FORM OF HORIZONTAL LINES ON THE NANONEEDLE MONITOR WAS NOTICED. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED WITH THE SAME DEVICE ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17919508 ↗
• MalfunctionAug 18, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  ON 7/20/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-3210-0043 NANONEEDLE SCOPE AND AN AR-3210-0041 NANOSCOPE OPERATIVE HIGH-FLOW SHEATH KIT HAD AN ISSUE. THE VISUAL QUALITY AND LIGHT SOURCE OUTPUT WAS NOT SUFFICIENT TO ADEQUATELY SEE. TO TROUBLESHOOT, THE NANO WAS RECALIBRATED TWICE AND PLUGGED THE CONSOLE INTO DIFFERENT POWER SOURCES AND THE ISSUE WAS NOT RESOLVED. THE CASE WAS COMPLETED BY OPENING A TRADITIONAL 2.7MM SCOPE. THIS WAS DISCOVERED DURING AN SUBTALAR ARTHROSCOPY PROCEDURE ON (B)(6) 2023, WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17572567 ↗