Arthrex® AR-3210-0030Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00888867230316), received between Aug 1, 2018 and Apr 12, 2024 — classified as 14 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 18, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 12, 2024Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT THE HOUSING OF THE CAMERA HEAD GETS HOT SUDDENLY AFTER 10 MINUTES USING AND IT IS UNABLE TO HOLD WITH HANDS. THE PROBLEM WAS NOTICED DURING INSPECTION. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THERE WAS NO CASE INVOLVEMENT REPORTED. NO FURTHER INFORMATION RECEIVED. *** UPDATE AHA 22-MAR-2024: DURING SURGERY THEY HAVE NOT FEEL THE HEAT INITIALLY, THEY HAVE CHECKED AFTER THAT FOR A PERIOD OF AN HOUR AT THAT TIME FOUND THAT CAMERA HEAD GETS HEATED UP RAPIDLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19095018 ↗
• MalfunctionMar 29, 2024Overheating of Device; Overheating of Device

  ON 04/18/2022, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA SEMS THAT AN AR-3210-0030 4K SYNERGYUHD4 C-MOUNT BB CAMERA HEAD WAS OVERHEATING DURING USE, THERE WAS NO PATIENT, USER, OR THIRD-PARTY INJURY. TO TROUBLESHOOT, THE CAMERA HEAD WAS TESTED WITH A TEMPERATURE SENSOR ATTACHED TO IT. THE CAMERA HEAD SHOWED AN INCREASE IN TEMPERATURE TO 43 DEGREES CELCIUS AFTER 45 MINUTES OF USE. THIS WAS DISCOVERED DURING USE ON 04/06/2022 WITH NO CASE/PATIENT INVOLVEMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON 04/21/2022, THE ARTHREX EMPLOYEE STATED THE FOLLOWING INFORMATION VIA EMAIL: THE EVENT OCCURRED DURING THE END OF A KNEE ARTHROSCOPY ON (B)(6) 2022. THE OVERHEATING WAS DETECTED AT THE END OF THE PROCEDURE BY THE SURGEON AND AFTER THIS INCIDENT, IT WAS TESTED BY ARTHREX MEXICO IN A MAINTENANCE VISIT ON 04/06/2022. NOBODY WAS HARMED BY THE OVERHEATING OF THE DEVICE, IT WAS JUST A COMMENT OF THE SURGEON THAT THE CAMERA HEAD WAS HOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19006043 ↗
• MalfunctionMar 29, 2024Excessive Heating; Excessive Heating

  ON 05/17/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT (2) AR-3210-0030 CAMERA HEADS ARE MALFUNCTIONING, ONE IS GETTING STUCK AS THE OTHER IS GETTING HOT. THIS WAS DISCOVERED DURING AN UNKNOWN TIME, WITH NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19004468 ↗
• MalfunctionFeb 14, 2024Melted; Melted

  ON 01/30/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3210-0030 CAMERA WAS DAMAGED, NOT WORKING PROPERLY, AND HOT TO THE TOUCH. APPEARED TO BE BURNT/MELTED AT ITS ATTACHMENT. THIS WAS DISCOVERED DURING AN ARTHROSCOPIC SHOULDER PROCEDURE WITH DR. (B)(6). NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18705165 ↗
• MalfunctionNov 27, 2023Loose or Intermittent Connection; Loose or Intermittent Connection

  ON 10/30/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06070551 THAT AN AR-3210-0030 CAMERA HEAD'S PRISM HAD BECOME LOOSE. THIS WAS DISCOVERED INTRA-OP. THE CASE WAS COMPLETED WITH ANOTHER DEVICE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18208893 ↗
• MalfunctionOct 27, 2023Material Puncture/Hole; Material Puncture/Hole

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3210-0030 CAMERA HAS A HOLE IN THE POWER CORD. THIS WAS DISCOVERED DURING USE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18020031 ↗
• MalfunctionJul 21, 2023Break; Defective Device; Break; Defective Device

  ON (B)(6) 2023, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-3210-0030 CAMERA HEADS CORD HAS EXPOSED WIRES, AND AN AR-3355-4030 ARTHROSCOPE IS PRODUCING A DARK IMAGE. THIS WAS DISCOVERED DURING THE EARLY START OF THE CASE. BOTH ITEMS WERE REPLACED BEFORE PROCEEDING WITH THE SURGERY. THERE WAS NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17373450 ↗
• MalfunctionJul 21, 2023Misfocusing; Misfocusing

  ON (B)(6)2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-3210-0030 CAMERA HEAD IS PRODUCING AN IMAGE THAT IS BLURRED AND VERY HARD TO FOCUS ON THE MONITOR. THIS OCCURRED DURING A CASE, THE ISSUE WAS ISOLATED TO THE CAMERA AS THE SCOPE WAS CHANGED AND THE ISSUE PERSISTED. THE CAMERA WAS THEN SWITCHED OUT AND THE CASE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17373446 ↗
• MalfunctionJul 20, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY SURGERY DISTORTION AND LINES WHERE DISPLAYED WHILE OPERATING. 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 17362023 ↗
• MalfunctionJul 13, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  ON 06/19/2023, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-3210-0030 CAMERA HEAD HAS NO SIGNAL. THIS OCCURRED DURING THE PREPARATION OF THE CASE. ADDITIONAL INFORMATION WAS PROVIDED ON 07/05/2023, IT WAS REPORTED THAT THIS EVENT OCCURRED DURING A SHOULDER ARTHROSCOPY PROCEDURE ON (B)(6) 2023. THE CASE WAS COMPLETED USING ANOTHER CAMERA.

  Patient problems: Insufficient Information

  MAUDE report 17318422 ↗
• MalfunctionJul 12, 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-3210-0030 CAMERA HEAD SCREEN WAS SHOWING STATIC LINES WITH A RED HUE DURING A CASE. THE CASE WAS COMPLETED 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 17304628 ↗
• MalfunctionJun 28, 2023Overheating of Device; Overheating of Device

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-3210-0030 CAMERA GOT VERY HOT. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17215445 ↗
• MalfunctionAug 18, 2020Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A DIAGNOSTIC LAPAROSCOPY PROCEDURE, THE PATIENT GOT BURNED. THE BURN WAS DISCOVERED BY THE PATIENT AFTER THE SURGERY. THE FOLLOWING DEVICES WERE USED DURING THE PROCEDURE: SS9-GYW50W108 / BATCH WO155094, AR-3210-0030, S/N (B)(4), AR-3210-0006, S/N (B)(4), AR-3351-5500, S/N (B)(4). NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: Burn, Thermal

  MAUDE report 10422377 ↗
• MalfunctionAug 1, 2018Overheating of Device

  IT WAS REPORTED THE CAMERA AR-3210-0030 GOT VERY HOT DURING A KNEE SCOPE AND BURNED THE SURGEON'S HAND. THE CASE WAS COMPLETED WITH A MINOR DELAY. HE WAS HOLDING ON THE GREY METAL PORTION OF THE CAMERA. AFTER THE CASE HE REVEALED A BLISTER ON HIS HAND AND IT WAS CONSIDERED TO BE A SECOND DEGREE BURN. NO REP WAS PRESENT AT THE CASE. IT WAS NOTED THAT THE DOCTOR PERFORMED THE REST OF HIS CASES THAT DAY WITHOUT ADDITIONAL ISSUES.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 7738581 ↗