Arthrex® AR-3200-0021Recalls & reported problems

Summary

The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 00888867197022), received between Feb 27, 2019 and Apr 8, 2026 — classified as 8 injuries, 49 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (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 57 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2026Defective Device

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY SURGERY THE LIGHT SOURCE OF THE DEVICE FAILED. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT 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 24818279 ↗
• MalfunctionFeb 6, 2025Overheating of Device; Overheating of Device

  ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-3200-0021 SYNERGYUHD4 CAMERA CONTROL UNIT HAD A BURNING SMELL AND WAS PHYSICALLY DAMAGED WHERE THE LIGHT CORD WAS INSERTED INTO THE UNIT. THE END OF THE LIGHT CORD SEEMED BURNED AND WAS BLACK AT THE END, AS WELL AS THE CONSOLE'S PLUG-IN. THE CASE WAS COMPLETED USING ANOTHER LIGHT CORD, AND AT THE END OF THE CASE, THE SAME ISSUE OCCURRED. IT IS UNKNOWN IF THE TWO LIGHT CORDS USED IN THE CASE WERE ARTHREX PRODUCTS. THERE WAS NO INJURY TO THE PATIENT, SURGEON, OR FACILITY STAFF. THE CASE WAS DELAYED FOR A COUPLE OF MINUTES, AND THERE WAS NO INFORMATION ON ADDED ANESTHESIA ADMINISTERED TO THE PATIENT. THERE WAS NO REP PRESENT AT THE CASE. THIS WAS DISCOVERED DURING A UROLOGY PROCEDURE ON (B)(6) 2025, WITH NO REPORT OF PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 01/13/2025: THE TWO UNKNOWN LIGHT CORDS REPORTED DURING THIS PROCEDURE ARE NON-ARTHREX PRODUCTS AND WERE DISCARDED. NO ADDITIONAL ANESTHESIA WAS ADMINISTERED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21320896 ↗
• MalfunctionJun 19, 2024Sparking; Sparking

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06577322 THAT AN AR-3200-0021 CCU CONSOLE HAD A SPARK COME FROM THE UNIT. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19567679 ↗
• MalfunctionMay 17, 2024Overheating of Device; Overheating of Device

  ON 4/19/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4)THAT AN AR-3200-0021 SYNERGYUHD4 CAMERA CONTROL UNIT WAS OVERHEATING AND GOT VERY HOT AND BURNED THROUGH THE LIGHT GUIDES AND A STAFF MEMBER'S CLOTHING. IT WAS STATED THAT THE STAFF MEMBER WAS NOT HURT, AND THE LIGHT GUIDES WERE A NON-ARTHREX PRODUCT. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 4/29/2024: THIS WAS DISCOVERED DURING A URETEROSCOPY PROCEDURE ON (B)(6) 2024. IT WAS STATED THAT THE EVENT WAS A "NEAR MISS" EVENT. THE OR TECH'S GOWN HAD TWO BURN HOLES CAUSED BY THE END OF THE LIGHT CABLE AFTER IT WAS REMOVED FROM THE CCU. NOTHING ELSE WAS PLUGGED INTO THE CCU AT THE TIME OF THE EVENT. THE END OF THE LIGHT SOURCE WAS TOO HOT TO TOUCH AND LOOKED SCORCHED. ONLY A BURNING SMELL CAME FROM THE OR TECH'S GOWN. THE CASE WAS COMPLETED AS PLANNED BEFORE IDENTIFYING THE LIGHT CABLE ISSUE (THE END OF THE LIGHT SOURCE HAD SCORCH MARKS THAT COULD NOT BE REMOVED DURING PROCESSING IN SPD; THEREFORE, THERE ARE CONCERNS ABOUT OVERHEATING AND THE CCU). THERE WAS NO DELAY IN THE CASE OR ADVERSE EFFECTS DUE TO THIS BEING A "NEAR MISS" EVENT. NO PHOTOS WERE TAKEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19343403 ↗
• MalfunctionApr 30, 2024Intermittent Loss of Power; Intermittent Loss of Power

  ON 04/03/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3200-0021 CONSOLE LIGHT CORD WOULD GO BLACK FOR A FEW SECONDS A FEW TIMES. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM. TECH SUPPORT RESOLVED ISSUE BY NAVIGATING TO LIGHT GUIDE AUTO SELECTION AND SWITCH IT TO OFF TO KEEP LIGHT GUIDE FROM TURNING ON AND OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19214918 ↗
• MalfunctionApr 23, 2024Intermittent Loss of Power; Intermittent Loss of Power

  IT WAS REPORTED THAT THE LIGHT SOURCE OF THE DEVICE IS SPORADICALLY WITHOUT FUNCTION. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. UPDATE AHA 08-APR-2024: THE FAILURE OCCURRED DURING A SURGERY BUT THERE WAS NO PATIENT HARM. THE LED ALSO CAME ON AGAIN, THERE WERE BRIEF INTERRUPTIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19166424 ↗
• MalfunctionApr 18, 2024Intermittent Loss of Power; Intermittent Loss of Power

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS (B)(4) THAT AN AR-3200-0021 ARTHREX SYNERGY UHD4 IS CAUSING LIGHT CORDS TO TURN OFF INTERMITTENTLY. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE, WITH NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19140206 ↗
• MalfunctionApr 17, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE HEAT FROM LIGHT SOURCE IS TOO MUCH, ITS BURNS THE LIGHT CABLE. THE PROBLEM WAS NOTICED AFTER 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 19123703 ↗
• MalfunctionMar 28, 2024Device Emits Odor; Device Emits Odor

  ON (B)(6) 2024, IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS (B)(4) THAT THE CONNECTION END THAT GOES INTO AN AR-3200-0021 CCU OF A LIGHT GUIDE HAD A BURNING SMELL. WHEN IT WAS REMOVED, IT WAS SMOKING AND HAD VISIBLE BURNS. THIS WAS DISCOVERED DURING SET UP, BEFORE THE PROCEDURE AND HAD NO EFFECT ON THE PATIENT. THE LIGHT CORD PRODUCT WAS FROM ANOTHER MANUFACTURER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18994955 ↗
• MalfunctionMar 22, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE LIGHT CABLE ADAPTER IS STUCK. IT CAN NOT BE TURNED AROUND AS USUAL. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. ALSO THERE WAS NO CASE INVOLVEMENT REPORTED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18961693 ↗
• InjuryMar 21, 2024Unintended Electrical Shock; Unintended Electrical Shock

  IT WAS REPORTED THAT THE CAMERA SHOCKED THE SURGEON WHEN HE TRIED TO FOCUS. ADDITIONAL INFORMATION OBTAINED 11/16/20: THE SALES REP REPORTED THAT THE SHOCK WAS LIKE A JOLT WHEN THE SURGEON WEN TO FOCUS. THE JOLT WAS FELT ON THE PALM OF HIS HAND. THE SURGEON FINISHED UP WITH THE CASE. THE SURGEON RECEIVED NO BURNS AND THE JOLT OCCURRED THROUGH HIS SURGICAL GLOVE.

  Patient problems: Insufficient Information

  MAUDE report 18956124 ↗
• MalfunctionJan 30, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE FIBER OPTIC CABLE BECOMES VERY HOT DURING OPTICAL CONNECTION. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THERE WAS NO CASE INVOLVEMENT REPORTED. NO FURTHER INFORMATION RECEIVED. UPDATE DW 22-DEC-2023: THE REPORTED ISSUE WAS NOTICED DURING A SURGERY. UPDATE SWIT 02-JAN-2024: A SHOULDER ARTHROSCOPY WAS PERFORMED. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE CABLE DID NOT COME IN CONTACT WITH THE PATIENT. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME LIGHT GUIDE CABLE. UPDATE DW 10-JAN-2024: FURTHER INFORMATION WERE PROVIDED THAT THE EVENT IS NOT RELATED TO THE USED CABLES AND NOT THE CCU WITH THE PART NUMBER AR-3240-5027. UPDATE DW 29-JAN-2024: THE NUMBER OF AFFECTED DEVICES AND LOT NUMBER OF THE DEFECTIVE CABLES WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18607925 ↗
• MalfunctionJan 5, 2024Device Emits Odor; Device Emits Odor

  ON 12/8/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3200-0021 CCU HAD AN ISSUE. THE FAN STOPPED WORKING, AND A BURNING SMELL CAME OUT. THIS WAS DISCOVERED AFTER USE. NO CASE INVOLVEMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON 1/2/2024, THE SALES REPRESENTATIVE PROVIDED ADDITIONAL INFORMATION VIA EMAIL: THIS WAS NOT REPORTED DURING A CASE. THEY NOTICED A BURNT SMELL COMING FROM THE CCU AND, AS A RESULT, CLOSED THE OR DOWN FOR THAT DAY AND DID NOT DO ANY CASES IN THAT OR UNTIL THE CCU WAS REPLACED THE NEXT DAY. NO SMOKE WAS NOTICED, AND NO ADVERSE EFFECTS TO THE STAFF OR SURGEON WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18453601 ↗
• MalfunctionDec 28, 2023Defective Device; Defective Device

  ON 11/30/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3200-0021 SYNERGY CONSOLE HAD A FEW OF THE CONNECTOR TEETH DAMAGED MAKING IT HARD TO PLUG IN CAMERAS. THIS WAS DISCOVERED AFTER THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18415283 ↗
• MalfunctionDec 8, 2023Computer Software Problem; Computer Software Problem

  ON 11/14/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3200-0021 CCU HAD ISSUES AFTER APPLYING THE 4.17.5 UPDATE. THERE WAS GREEN STATIC WHILE USING MULTIPLE CAMERA HEADS (THESE CAMERA HEADS WERE THEN TESTED ON A DIFFERENT CONSOLE AND HAD NO ISSUES), CASES ENDING UNEXPECTEDLY, FOLLOWED BY A NEW CASE AUTO-STARTING WITH PATIENT INFORMATION FROM A SEPARATE ROOM, DUPLICATED CASES, AND NO PHOTOS SAVING FROM THE CASES. BEFORE THE UPGRADE, THE ACCOUNT HAD NO ISSUES WITH THEIR CCU. THIS WAS DISCOVERED DURING THEIR FIRST CASE SINCE THE UPDATE ON 11/14/2023, WITH NO REPORTED ADVERSE EVENT OR PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18292567 ↗
• MalfunctionDec 8, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  ON 11/14/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06401201 THAT AN AR-3200-0021 CCU HAD A DARK SCREEN/IMAGE AND COULD NOT VISUALLY SEE THE PICTURE AS WELL AS PRIOR USES. TO TROUBLESHOOT, TRIED DIFFERENT F/O CABLES AND CHECKED TABLET CONTROLS TO MAKE SURE THE LIGHT SOURCE WAS TURNED UP, AND IT WAS. THE CASE WAS COMPLETED BY SWITCHING OUT TOWERS AND USING A DIFFERENT CCU BOX WITH NO ISSUES WITH THE LIGHT SOURCE. THERE WAS NO REPORTED DELAY IN THE CASE. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18292367 ↗
• MalfunctionDec 1, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  ON 11/07/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06393791 THAT AN AR-3200-0021 CCU IS SHOWING LINES ON THE SCREEN. THIS WAS DISCOVERED DURING USE IN A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18252541 ↗
• MalfunctionNov 28, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  ON (B)(6)/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06261780 THAT AN AR-3200-0021 CCU WAS PRODUCING LINES ACROSS THE SCREEN. THIS OCCURRED DURING A CASE WHERE ANOTHER DEVICE WAS USED TO COMPLETE THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 18223273 ↗
• MalfunctionNov 15, 2023Computer Software Problem; Computer Software Problem

  ON 10/20/2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA (B)(4) THAT AN AR-3200-0021 CCU WAS EXPERIENCING AN ISSUE WITH (OVERSIZED LOG FILES IN /VAR/LOG DIRECTORY) AFTER BEING UPDATED TO V4.15.0. THIS OCCURRED DURING A CASE WITH NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18141846 ↗
• MalfunctionNov 15, 2023Poor Quality Image; Poor Quality Image

  ON 10/20/2023 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3200-0021 CCU HAS A GRAINY IMAGE. THIS WAS DISCOVERED DURING USE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18141811 ↗
• MalfunctionNov 10, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3200-0021 CAMERA PORT IS BROKEN. THIS WAS DISCOVERED DURING USE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18111775 ↗
• MalfunctionNov 10, 2023Defective Device; Defective Device

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3200-0021 CCU PRODUCED A "SYSTEM ERROR" ALARM. THIS OCCURRED DURING A PROCEDURE, WHEN THE DEVICE WAS RESTARTED, THE MESSAGE WAS GONE. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18111036 ↗
• MalfunctionNov 6, 2023Break; Break

  IT WAS REPORTED THAT THE LIGHT IS BROKEN. THERE WAS NO HARM FOR THE PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18074973 ↗
• MalfunctionNov 3, 2023Optical Problem; Optical Problem

  ON 10/19/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(6) THAT AN AR-3200-0021 CCU WAS PRODUCING LIGHT SOURCES THAT KEEP GOING OUT. THE CASE WAS COMPLETED USING THE SAME CONSOLE WITH NO REPORTED ADVERSE EFFECTS ON THE PATIENT. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18067497 ↗
• MalfunctionOct 25, 2023Display or Visual Feedback Problem; Image Display Error/Artifact; Display or Visual Feedback Problem; Image Display Error/Artifact

  IT WAS REPORTED THAT THE DATA TRANSFER/DATA PLAYBACK IS POOR. THE PICTURE APPEARS TO BE NOISY. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18003035 ↗