Arthrex® AR-3210-0029Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00888867216570), received between Feb 21, 2018 and Nov 25, 2025 — classified as 3 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (12 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 25, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A SURGERY THE CAMERA GETS VERY HOT WHEN IT IS USED IN COMBINATION WITH THE CONSOLE. IT RESULTS IN IMAGE FAILURES, LEADING TO NO HDMI SIGNAL. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23644536 ↗
• MalfunctionJun 3, 2024Overheating of Device; Overheating of Device

  ON 05/06/2024 IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-3210-0029 CAMERA HEAD WAS GETTING EXTREMELY HOT. THIS OCCURRED DURING A CASE WITH NO EFFECT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19447291 ↗
• MalfunctionJun 1, 2024Material Fragmentation; Material Fragmentation

  ON 08/29/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3210-0029 SCOPE HAS PARTICLES COMING OUT OF THE CAMERA FROM AN UNKNOWN AREA. THIS OCCURRED DURING USE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19441975 ↗
• MalfunctionApr 8, 2024Excessive Heating; Excessive Heating

  ON 01/03/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT A AR-3210-0029 CAMERA HEAD IS OVERHEATING, AND IT IS HOT TO THE TOUCH. THIS OCCURRED DURING A CASE. THERE WAS NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19063714 ↗
• MalfunctionApr 5, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED ON (B)(6) 2023 BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-3210-0029 CAMERA IS GETTING HOT AND SHAKING A LOT. CASE INVOLVEMENT, NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19055964 ↗
• MalfunctionApr 4, 2024Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT AFTER USE THE CAMERA IS VERY HOT, AND IT IS DIFFICULT TO HOLD IT IN THE HAND. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THIS WAS NOTICED AFTER THE SURGERY. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19042565 ↗
• MalfunctionFeb 20, 2024Overheating of Device; Excessive Heating; Overheating of Device; Excessive Heating

  IT WAS REPORTED THAT THE DEVICE GETS VERY HOT. THE PROBLEM WAS NOTICED BEFORE THE SURGERY. THERE WAS NO HARM FOR THE PATIENT, OPERATOR OR THIRD PARTY REPORTED. ALSO THERE WAS NO CASE INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18741202 ↗
• MalfunctionFeb 7, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY AFTER THE FIRST HOUR, THE CAMERA STARTED TO GET MORE HOT THAN USUAL. THE NURSE HAD WRAPPED THE DEVICE IN AN ADDITIONAL FABRIC AROUND IT TO KEEP HOLDING IT UNTIL THE END OF SURGERY. 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 18660891 ↗
• MalfunctionFeb 7, 2024Overheating of Device; Overheating of Device

  INITIALLY THE CUSTOMER REPORTED ON THE 14TH OCTOBER THAT THE CAMERA HEAD HAD TEMPERATURE ISSUES. AND NO FURTHER INFORMATION WERE PROVIDED. ON THE 16TH DECEMBER THE CUSTOMER FORWARDED FURTHER INFORMATION THAT THE DEVICE WAS STILL USED DURING DIFFERENT SURGERIES AND PROVIDED AN OVERVIEW WHEN THE DEVICE BECAME TO HOT TO HOLD DURING THIS SURGERIES. 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. NO FURTHER INFORMATION RECEIVED. ON (B)(6) THE REPORTED DEVICE BECAME "TOO" HOT AFTER 14 MIN DURING A SURGERY. ON (B)(6) 2022 THE REPORTED DEVICE BECAME "TOO" HOT AFTER 30 MIN DURING A SURGERY. ON (B)(6) THE REPORTED DEVICE BECAME "TOO" HOT AFTER 35 MIN DURING A SURGERY. IT WAS FURTHER REPORTED THAT THE DEVICE COULD BE USED WITHOUT ISSUES IN SURGERIES IN BETWEEN. 09-MAY-2023 UPDATE DW FURTHER INFORMATION WERE PROVIDED THAT THE CUSTOMER WILL RETURN THE CONSOLE WHICH WAS USED WITH THE CAMERA HEAD FOR FURTHER "EVALUATION".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18660737 ↗
• MalfunctionJan 12, 2024Overheating of Device; Overheating of Device

  ON 12/20/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3210-0029 CAMERA HEAD PLUG IS BURN UP AND WILL NOT CONNECT TO THE CAMERA UNIT. NO CASE INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 18502497 ↗
• MalfunctionAug 23, 2023Overheating of Device; Overheating of Device

  ON 7/25/2023, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-3210-0029 4K SYNERGYUHD4 BB CAMERA HEAD GOT HOT AND OVERHEATED DURING A PROCEDURE. IT WAS DISCOVERED DURING A CASE THAT THE PATIENT GOT A BURN MARK/SPOT DUE TO THE CAMERA/CORD BEING TOO HOT, NOT INDICATED AS TO WHERE ON THE PATIENT. THEY WERE NOT SURE IF IT WAS THE CAMERA CORD OR THE CAMERA ITSELF THAT WAS HAVING ISSUES. THIS OCCURRED DURING USE IN AN UNSPECIFIED PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON 8/2/2023, THE FACILITY REPRESENTATIVE STATED THE FOLLOWING INFORMATION VIA EMAIL: THIS OCCURRED DURING A LEFT KNEE ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2023. THE SEVERITY OF THE PATIENT'S BURN WAS 1ST DEGREE, THE STAFF DID NOT OBTAIN ANY BURNS. IT WAS DETERMINED THAT WHEN COMPLETING THE CASE, THE CAMERA HEAD DID NOT OVERHEAT, BUT THE BLUE LIGHT CORD DID, AN AR 3240 -5027 FUSED LIGHT CABLE WITH LOT NUMBER WO178440. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WAS NO OTHER IMPACT REPORTED.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 17606150 ↗
• MalfunctionJul 27, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT GREEN STRIPES ON THE SURGICAL MONITOR, INTRAOPERATIVE. THERE WAS NO HARM FOR THE PATIENT, OPERATOR OR THIRD PARTY REPORTED. FURTHER INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17408396 ↗
• MalfunctionJul 21, 2023Connection Problem; Connection Problem

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-3210-0029 CAMERA HEAD HAS A BAD CONNECTION. THIS OCCURRED DURING A CASE, ANOTHER CAMERA WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17373937 ↗
• MalfunctionJul 21, 2023Connection Problem; Connection Problem

  ON (B)(6)2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-3210-0029 CAMERA HEAD HAS A BAD CONNECTION. THIS OCCURRED DURING A CASE, ANOTHER CAMERA WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17373838 ↗
• MalfunctionJul 21, 2023Connection Problem; Connection Problem

  ON (B)(6)2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-3210-0029 CAMERA HEAD HAS A BAD CONNECTION. THIS OCCURRED DURING A CASE, ANOTHER CAMERA WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17373812 ↗
• MalfunctionJul 21, 2023Display or Visual Feedback Problem; Connection Problem; Display or Visual Feedback Problem; Connection Problem

  ON (B)(6)2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-3210-0029 CAMERA HEAD HAS A BAD CONNECTION. THIS OCCURRED DURING A CASE, ANOTHER CAMERA WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17373741 ↗
• MalfunctionJul 14, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-3210-0029 CAMERA HEAD WOULD SHUT DOWN AND NOT PROJECT AN IMAGE WHEN THE ABLATION DEVICE WAS BEING USED DURING THE CASE. THE CASE WAS COMPLETED BY SWAPPING OUT THE CAMERA FOR A NEW ONE. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE, WITH NO REPORTED ADVERSE EVENT OR PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17324650 ↗
• 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-3210-0029 CAMERA PHOTOS ARE FUZZY. RF BLOCKER IS FADING. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17319650 ↗
• MalfunctionJul 13, 2023Display or Visual Feedback Problem; Misfocusing; Display or Visual Feedback Problem; Misfocusing

  ON 06/21/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-3210-0029 CAMERA HEAD WAS GOING IN AND OUT OF FOCUS. THIS OCCURRED DURING A CASE, WITH NO PATIENT EFFECT REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17319303 ↗
• MalfunctionJul 13, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  ON (B)(6)2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT (QTY. 3) OF AN AR-3210-0029 4K SYNERGYUHD4 BB CAMERA HEAD WOULD GO BLACK WHEN PRESSING THE WAND IN THE MIDDLE OF THE CASE AND THEN IT WOULD NOT GIVE A CLEAR IMAGE AFTER. THE CASE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER CAMERA HEAD. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE, WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17316860 ↗
• MalfunctionJul 13, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT (QTY. 3) OF AN AR-3210-0029 4K SYNERGYUHD4 BB CAMERA HEAD WOULD GO BLACK WHEN PRESSING THE WAND IN THE MIDDLE OF THE CASE AND THEN IT WOULD NOT GIVE A CLEAR IMAGE AFTER. THE CASE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER CAMERA HEAD. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE, WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17316852 ↗
• MalfunctionJul 13, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  ON 6/16/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT (QTY. 3) OF AN AR-3210-0029 4K SYNERGYUHD4 BB CAMERA HEAD WOULD GO BLACK WHEN PRESSING THE WAND IN THE MIDDLE OF THE CASE AND THEN IT WOULD NOT GIVE A CLEAR IMAGE AFTER. THE CASE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER CAMERA HEAD. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE, WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17316831 ↗
• MalfunctionJul 13, 2023Loss of Power; Loss of Power

  ON 06/15/2023, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-3210-0029 CAMERA HEAD SHUT OFF. THIS OCCURRED DURING A CASE, WITH NO PATIENT EFFECT REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 17316803 ↗
• MalfunctionJul 13, 2023Device Damaged Prior to Use; Defective Device; Device Damaged Prior to Use; Defective Device

  ON 06/14/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-3210-0029 CAMERA CORD IS DAMAGED. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17315197 ↗
• MalfunctionJul 12, 2023Display or Visual Feedback Problem; Misfocusing; Display or Visual Feedback Problem; Misfocusing

  ON (B)(6) 2023, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT (QTY. 2) OF AN AR-3210-0029 CAMERA HEAD HAD AN ISSUE. THE C-MOUNT ATTACHED TO THE CAMERA GOES IN AND OUT OF WHITE BALANCE AND NOT FOCUSING. TRIED TROUBLESHOOTING BUT WAS UNABLE TO GET IT TO WORK ACCORDINGLY. THE CASE WAS COMPLETED SUCCESSFULLY BY REPLACING IT WITH ANOTHER CAMERA HEAD. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE, WITH NO ADVERSE EVENT OR PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17304598 ↗