Arthrex® AR-3210-0040Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00888867287839), received between Jan 20, 2020 and Jan 2, 2025 — classified as 5 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• InjuryJan 2, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING A KNEE NANONEEDLE STUDY ONE PATIENT HAD A VASOVAGAL REACTION DURING/AFTER THE INTERVENTION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Arthritis; Syncope/Fainting

  MAUDE report 21062316 ↗
• MalfunctionJun 18, 2024No Display/Image; No Display/Image

  IT WAS REPORTED THAT DURING AN ANKLE PROCEDURE THE SURGEONS USED TWO OF THE AR-3210-0040, NASOSCOPE HANDPIECES SAME LOT NUMBER: 1909036. THE SURGEON ENTERED THE JOINT AND THE HANDPIECE WENT BLACK. THE SURGEON USED A 2ND AR-3210-0040 AND THE SAME ISSUE OCCURRED. THE CASE WAS COMPLETED USING A THIRD AR-3210-0040, DIFFERENT LOT NUMBER.

  Patient problems: Insufficient Information

  MAUDE report 19562762 ↗
• MalfunctionJun 14, 2024Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT DURING WRIST ARTHROSCOPY, RIGHT, AFTER ABOUT 3-5 MINUTES OF THE SURGERY THE IMAGE WAS BLURRED, THE VIEWING WINDOW TURNED SMALLER AND SMALLER. IT LOOKED LIKE IT WAS LIQUID INSIDE THE DEVICE . THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. 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. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19539348 ↗
• MalfunctionJun 14, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  ON 12/02/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-3210-0040 SCREEN HAS A BIG GREY SQUARE. THIS OCCURRED DURING A CASE WITH NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19537687 ↗
• MalfunctionJun 14, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, SURGEON COMPLAINT THAT THE IMAGE KEPT GOING RED. TWO CAMERA HEADS WERE SWAPPED BUT THE IMAGE CONTINUED TO HAVE RED TINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19537390 ↗
• MalfunctionJun 14, 2024No Display/Image; No Display/Image

  IT WAS REPORTED THAT DURING AN ELBOW ARTHROSCOPY & DEBRIDEMENT SURGERY AFTER THE FIRST HALF OF THE PROCEDURE WENT AS EXPECTED THE IMAGE WAS UNEXPECTEDLY LOST. THE SHAVER HAD JUST ENTERED THE JOINT, BUT THERE WAS NO CONTACT AND/OR DAMAGE TO THE NANOSCOPE SHEATH/CAMERA ITSELF. THE DEVICE INTERMITTENTLY FLASHED AND GAVE A SCREEN/IMAGE WITH GREY STRIPES ON THE MONITOR. A SECOND NANOSCOPE WAS OPENED AND CONNECTED. THE SYSTEM WANTED TO GO THROUGH A FULL REBOOT BUT THEN THE HANDPIECE DID NOT WORK. THEREFORE A THIRD NANOSCOPE WAS OPENED AND THE SURGEON WAS ABLE TO FINISH THE SURGERY SUCCESSFULLY WITH THE THIRD ONE.THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19537107 ↗
• MalfunctionJun 14, 2024Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED IN THE MIDDLE OF THE PROCEDURE THE IMAGE WENT BLACK. ATTEMPTED TO PLUG/UNPLUG AR-3210-0040 AND TROUBLESHOOT, BUT NO AVAIL. OPENED NEW NANOSCOPE HANDPIECE AND COMPLETED THE CASE WITHOUT INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19535767 ↗
• MalfunctionJun 13, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE DURING A CASE, THE MONITOR FOR THE NANOSCOPE, AR-3210-0040, FLICKERED BLACK A COUPLE OF TIMES BEFORE GOING COMPLETELY BLACK. ACCORDING TO THE SURGEON, IT "SEEMED LIKE THE SCOPE BURNT OUT." THE SURGEON OPENED UP ANOTHER HANDPIECE (LOT: 2002036) AND WAS ABLE TO COMPLETE THE CASE USING THAT PART. THERE WAS NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19534315 ↗
• MalfunctionJun 5, 2024Defective Device; Defective Device

  ON 05/11/2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-3200-0040 NANOSCOPE HANDPIECE HAD AN ISSUE. DURING A WRIST SCOPE PROCEDURE ON (B)(6) 2022, THE CAMERA LIGHT DID NOT TURN ON AT ALL EVEN WHEN CONNECTED TO THE CONSOLE. THE CASE WAS COMPLETED WITH A SMALL JOINT SCOPE READY AS A BACKUP, NO PATIENT HARM. THIS WAS DISCOVERED DURING USE WITH NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19470094 ↗
• MalfunctionJun 5, 2024Optical Obstruction; Optical Obstruction

  IT WAS REPORTED ON 08/10/2022 BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-3210-0040 NANOSCOPE LENS IS CLOUDY. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19468188 ↗
• MalfunctionJun 4, 2024Image Orientation Incorrect; Image Orientation Incorrect

  IT WAS REPORTED ON 11/11/2022 BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-3210-0040 HANDPIECE IMAGE VIEW CHANGED AND WOULD NOT CHANGE BACK. CASE INVOLVEMENT, NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19459133 ↗
• MalfunctionMay 27, 2024Fitting Problem; Fitting Problem

  ON 08/02/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AR-3210-0040 NANOSCOPE HANDPIECE TROCARS DIDN'T FIT INTO CANNULAS.

  Patient problems: Insufficient Information

  MAUDE report 19402300 ↗
• MalfunctionMay 24, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  ON 11/29/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-3210-0040 NANOSCOPE HANDPIECE STOPPED DISPLAYING IMAGES. THIS WAS DISCOVERED DURING USE IN A PROCEDURE PERFORMED ON (B)(6) 2021. A SECOND HANDPIECE WAS OPENED, BUT THE ISSUE PERSISTED. TECH SUPPORT ADVISED TO RESTART THE NANOSCOPE CONSOLE. THE SURGEON CONTINUED THE PROCEDURE, AND THE CONSOLE BEGAN WORKING AGAIN AFTER BEING RESET. THE CASE WAS COMPLETED WITH THE SECOND HANDPIECE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19397516 ↗
• MalfunctionMay 24, 2024No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE NANOSCOPE HAS BUTTONS THAT ARE NOT WORKING PROPERLY. WHEN PUSHED, THE BEEPING SOUND OCCURS AS EXPECTED BUT NO IMAGE CAPTURE IS INITIATED ON THE CONSOLE. THE CASE WAS COMPLETED BY INITIATING IMAGE CAPTURE USING THE TOUCHSCREEN ON THE NANOSCOPE CCU.

  Patient problems: Insufficient Information

  MAUDE report 19391535 ↗
• MalfunctionMay 23, 2024No Display/Image; No Display/Image

  IT WAS REPORTED ON 10/07/2022 BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-3210-0040 HANDPIECE PIXELS DIED ON THE IMAGE. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19386500 ↗
• MalfunctionMay 23, 2024Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT DURING A WRIST ARTHROSCOPY THE PICTURE FLICKERED WITH THE DEVICE. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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 19383812 ↗
• MalfunctionMay 22, 2024Image Display Error/Artifact; Image Display Error/Artifact

  IT WAS REPORTED THAT DURING A PROCEDURE, SURGEON COMPLAINED THAT THE IMAGE KEPT GOING RED. TWO CAMERA HEADS WERE SWAPPED BUT THE IMAGE CONTINUED TO HAVE RED TINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19372866 ↗
• MalfunctionMay 22, 2024Crack; Crack

  IT WAS REPORTED ON 07/28/2022 BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-3210-0040 NANOSCOPE LENS IS CRACKED. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19371148 ↗
• MalfunctionMay 22, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING A WRIST JOINT ARTHROSCOPY SURGERY THE TROCAR SLEEVES WERE NOT CONTINUOUS AND ONLY WITH EFFORT THE TROCAR TIP WAS INSERTED. 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 19370268 ↗
• MalfunctionMay 15, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  ON 07/26/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-3210-0040 NANOSCOPE HANDPIECE KIT AFTER PLUGGED IN DURING AN UNKNOWN CASE THE LENS BECAME BLACK, THE SCREEN NEVER CAME BACK ON. THERE WAS NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19319010 ↗
• MalfunctionMay 14, 2024Fitting Problem; Fitting Problem

  IT WAS REPORTED ON 03/28/2022 BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-3210-0040 OBTURATOR DOES NOT FIT IN THE SHEATH. THIS OCCURRED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19312930 ↗
• MalfunctionMay 10, 2024Misfocusing; Misfocusing

  IT WAS REPORTED THAT DURING A NANOSCOPY SURGERY AFTER CONNECTING THE DEVICE, THERE WAS AN IMAGE FOR A WHILE AND THEN IT DISAPPEARED. AFTER CHANGING THE NANOSCOPE TO A NEW ONE, EVERYTHING WORKED FINE. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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 19286340 ↗
• MalfunctionApr 26, 2024Fitting Problem; Fitting Problem

  ON (B)(6) 2021 IT WAS REPORTED BY ARTHREX EMPLOYEE VIA SEMS THAT AN AR-3210-0040 NANOSCOPE OBTURATOR DID NOT PASS THROUGH BOTH SHEATHS. THIS WAS DISCOVERED DURING USE IN AN UNSPECIFIED CASE PERFORMED ON (B)(6) 2021. THE CASE WAS COMPLETED USING A NEW PRODUCT WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19192998 ↗
• MalfunctionApr 10, 2024Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT STAFF TRIED TO TAKE A PICTURE WITH THE BUTTON ON THE NANOSCOPE HANDPIECE, AR-3210-0040, BUT COULDN'T. EVEN WHEN IT WAS INSERTED AND REMOVED, IT STILL DID NOT WORK PROPERLY. HOWEVER, IT WAS USABLE WHEN IT WAS PLUGGED IN AGAIN AT THE END OF THE OPERATION. NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19081186 ↗
• MalfunctionOct 24, 2022Material Fragmentation

  ON (B)(6) 2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-3210-0040 NANO SCOPE PRODUCED METAL SHAVINGS DURING A WRIST ARTHROSCOPY. THE TROCAR INSERTION KEPT GETTING IN THE JOINT SPACE SO PIXELS AT THE END OF THE CAMERA DIED OUT. IT WAS UNPLUGGED AND PLUGGED BACK IN TO TRY AND CLEAR THE PIXELS WITH NO SUCCESS. THE OTHER TROCAR WAS INSERTED BUT HAD THE SAME RESULT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15657681 ↗