Arthrex® AR-200CRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00888867200685), received between Nov 21, 2019 and Jun 6, 2024 — classified as 2 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Failure to Power Up” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 6, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED, THAT AN ERROR MESSAGE WAS DISPLAYED ON THE AR-200C (SN (B)(6)) DURING THE USE OF THE AR-200M (SN (B)(6)). THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO PARTS BROKE INSIDE THE PATIENT. THE MINIMALLY INVASIVE DISTAL METATARSAL OSTEOTOMY (DMMO) SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE FROM STRYKER. A SWITCH OF THE SURGICAL TECHNIQUE WAS NECESSARY, AS A DIFFERENT DEVICE WAS USED. IT WAS NOT NECESSARY TO DO A SECOND SURGERY. UPDATE AVOE 01-FEB-2021: THEY COULDN'T OPERATE THE PATIENT WITH THE DEVICE AT ALL, BECAUSE THE DEVICE DIDN'T WORK AT ALL. NO LARGER OR NEW INCISIONS WERE NECESSARY IN THE PATIENT DUE TO THE USE OF THE STRYKER DEVICES, SINCE AN ARTHREX BURR WAS ALSO USED. THE DURATION OF THE OPERATION INCREASED BY 5-10 MIN DUE TO THE DEFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19474039 ↗
• MalfunctionApr 17, 2024Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT DURING A MIS FOREFOOT SURGERY THE DEVICE DID NOT WORK. THE DISPLAY SHOWED WITH BOTH AND DEVICES AND HAND PIECES THE ERROR MESSAGE "HAND PIECE NOT CONNECTED". THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE FROM ANOTHER MANUFACTURER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19127278 ↗
• MalfunctionMar 28, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 03/12/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06511576 THAT AN AR-200C SHAVER CONSOLE IRRIGATION TUBING IS COMING OUT OF THE CONSOLE. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18995823 ↗
• MalfunctionJan 22, 2024Break; Break

  ON 1/2/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4), THAT THE ARTHREX CONSOLE, AR-200C, TUBING MECHANISM BROKE DURING A CASE. OCCURRED DURING A CASE WITH NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18553889 ↗
• MalfunctionJan 8, 2024Defective Component; Defective Component

  ON 12/12/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-200C CONSOLE OUTLET IS DAMAGED. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18465440 ↗
• InjuryDec 7, 2023Defective Device; Defective Device

  ON 11/10/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-200M MOTOR WITH CABLE 3.5M WAS NOT RECOGNIZED ON THE CONSOLE AND THE CUSTOMER HAD TO BE OPENED UP INSTEAD OF DOING MINIMALLY INVASIVE SURGERY. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE. ADDITIONAL INFORMATION RECEIVED ON 11/14/2023: THIS WAS DISCOVERED DURING A MIS BUNION PROCEDURE. INSTEAD OF DOING MINIMALLY INVASIVE SURGERY, THE INCISION WAS REQUIRED TO BE OPENED, AND THE BONE WAS EXCISED WITH A RONGEUR AND A SAW. THE PATIENT'S QUALITY OF LIFE WAS NOT REDUCED; HEALING TIME AND OUTCOME OF THE SURGERY MAY HAVE BEEN AFFECTED. THE CASE WAS COMPLETED BY OPENING THE INCISION AND REVERTING TO AN OPEN PROCEDURE. THERE WAS A REPORTED 30-45 MINUTE DELAY IN THE PROCEDURE. THERE WAS NO ADDITIONAL ANESTHESIA ADMINISTERED. THE PATIENT'S HEALTH STATUS WAS STATED AS "OKAY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18282184 ↗
• MalfunctionNov 29, 2023Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  ON 11/6/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-200C ARTHREX AR-200 CONSOLE WAS UNABLE TO CHANGE THE TORQUE OF THE DEVICE. IT WAS STATED THAT THE RPM ADJUSTS, TORQUE ADJUSTMENTS ARE NOT MAKING ANY DIFFERENCE, ISSUE PERSISTS WITH DIFFERENT MOTORS, NO ERROR MESSAGES, CONSOLE RESTARTED, RESET FACTORY SETTINGS, FW/REV DO NOT RESOLVE THE ISSUE EITHER. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18229418 ↗
• MalfunctionNov 27, 2023Failure to Power Up; Failure to Power Up

  ON 11/08/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-200C CONSOLE WILL NOT TURN ON. THIS WAS DISCOVERED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18209655 ↗
• MalfunctionOct 31, 2023Power Problem; Power Problem

  ON 10/02/2023, IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS-06046517 THAT AN AR-200C CONSOLE BURR HAS NO TORQUE. THE FACILITY CHANGED THE HANDPIECE BUT HAD NO SUCCESS. THIS WAS DISCOVERED DURING USE WITH NO PATIENT HARM. THE CASE WAS COMPLETED BUT TOOK LONGER AND HAD TO FREEHAND SOME DEBRIDEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18040720 ↗
• MalfunctionOct 25, 2023Electrical Shorting; Electrical Shorting

  ON 09/26/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-200C CONSOLE, AN AR-300B BURR ATTACHMENT, AND AN AR-200M MOTOR WITH CABLE WERE BEING USED IN A CASE AND THE CONSOLE KEPT SHORTING OUT, AND ANY TIME IT WAS TURNED OFF IT SHUT OFF RIGHT WAY. THE HANDPIECE WAS MALFUNCTIONING. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION WAS PROVIDED ON 09/28/2023. IT WAS REPORTED THAT THIS EVENT OCCURRED DURING A MIS BUNION CASE ON (B)(6) 2023. THERE WAS NO ISSUE WITH THE AR-300B. THE CASE WAS COMPLETED UTILIZING ANOTHER AR-200M. THERE WAS NO EFFECT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18003182 ↗
• MalfunctionOct 23, 2023Failure to Power Up; Failure to Power Up

  ON 9/28/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06043745 THAT AN AR-200C ARTHREX AR-200 CONSOLE WOULD NOT POWER ON DURING A CASE. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE, WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17987269 ↗
• MalfunctionOct 19, 2023Unexpected Shutdown; Unexpected Shutdown

  ON 9/20/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(6) THAT AN AR-200C ARTHREX AR-200 CONSOLE STOPPED WORKING DURING A CASE. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE, WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17965539 ↗
• MalfunctionSep 14, 2023Break; Device Damaged by Another Device; Break; Device Damaged by Another Device

  ON (B)(6)2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-200C ARTHREX AR-200 CONSOLE AND AN OEM06202400 FOOTSWITCH S-N1 WERE NOT WORKING DURING A CASE. ONE OF THE PRONGS ON THE FOOTSWITCH BROKE OFF IN THE CONSOLE, AND NOW NEITHER WORKS. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE, WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17744227 ↗
• MalfunctionSep 6, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  ON 08/09/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-200C CONSOLES SCREEN WOULD TURN WHITE. THIS OCCURRED DURING A PROCEDURE, AND ACCORDING TO THE REPORTING THERE PATIENT WAS AFFECTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 17689020 ↗
• MalfunctionAug 24, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN OEM06202400 FOOTSWITCH S-N1 AND AN AR-200C CONSOLE HAD AN ISSUE. DURING A CASE ON (B)(6) 2026, THE CONSOLE STOPPED DETECTING THE FOOTSWITCH. THE CONSOLE SOMEHOW GOT A SIZABLE CRACK IN THE INPUT, AND A PIN IN THE FOOTSWITCH BROKE OFF AS WELL, LIKELY DUE TO THE FAULTY CONSOLE. THIS OCCURRED DURING USE IN AN UNSPECIFIED PROCEDURE WITH NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON (B)(6) 2023, THE SALES REPRESENTATIVE PROVIDED THE FOLLOWING INFORMATION: THIS OCCURRED DURING AN MIS BUNIONECTOMY PROCEDURE. WHEN THE CONSOLE DID NOT RECOGNIZE THE FOOTSWITCH, THE MESSAGE DISPLAYED WAS A ¿?¿ AND AN IMAGE OF THE FOOTSWITCH. THE OSTEOTOMY WAS COMPLETED WITH AN MIS BURR PLACED IN A TPX BURR. THERE WAS A 10-MINUTE DELAY AS THEY ATTEMPTED TO FIX THE CONSOLE, AND NO ADVERSE EFFECT TO THE PATIENT OR OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17610282 ↗
• MalfunctionAug 4, 2023Defective Device; Defective Device

  ON 7/6/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-200C CONSOLE WOULD NOT RECOGNIZE THE FOOT PEDAL. THE ICON OF A CELLPHONE WITH AN EXCLAMATION MARK CAME ON AND WOULDN'T GO AWAY, AND THE CONSOLE WOULD NOT WORK AFTER TROUBLESHOOTING. THE ISSUE WAS DISCOVERED DURING THE CASE, AND THEY HAD TO CONNECT TO A TPS DRILL TO FINISH THE CASE WITH NO PATIENT EFFECT. THIS OCCURRED DURING USE IN AN UNSPECIFIED PROCEDURE WITH NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED. ON 8/2/2023, THE SALES REPRESENTATIVE PROVIDED THE FOLLOWING INFORMATION VIA EMAIL: THIS EVENT OCCURRED DURING A MET OSTEOTOMY PROCEDURE ON (B)(6) 2023. THEY KEPT GETTING THE SIGNAL TO CALL FOR SERVICE AND ATTACHED THE BURR TO TPS TO FINISH THE CASE. THERE WAS NO ADVERSE EFFECT OR PROCEDURAL DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17462388 ↗
• MalfunctionJul 18, 2023Failure to Power Up; Failure to Power Up

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-200C CONSOLE WILL NOT POWER ON. THIS OCCURRED DURING A CASE, WITH NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17343584 ↗
• MalfunctionJul 14, 2021Connection Problem; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT DURING A MINIMALLY INVASIVE SURGERY, THE BURRS WOULD NOT HOLDING SECURELY INTO THE END OF THE HAND PIECE. THIS MAKES IT SO THE BURR CANNOT SPIN IN THE HAND PIECE AND WORK AT ALL. THE MIS CONSOLE WASN¿T WORKING PROPERLY EITHER. THE IRRIGATION TUBING WHEELS DO NOT ROTATE OR MOVE WHEN THE DEVICE IS ACTIVATED THEREFORE NONE OF THE IRRIGATION EXPELS OUTWARD. THE SURGEON HAD TO REVERT TO AN OPEN PROCEDURE AND MAKE THE OSTEOTOMIES WITH A SAW AND NOT HAVE THE MINIMAL INVASIVE OUTCOME DESIRED AND CONSENTED BY THE PATIENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12165210 ↗
• InjuryNov 21, 2019Failure to Power Up

  IT WAS REPORTED PRIOR TO THE START OF A MIS BUNION PROCEDURE, THE AR-200C CONSOLE WOULD NOT TURN ON. THE REP STATED THAT THE CASE WAS RESCHEDULED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION RECEIVED ON 10/30/2019: THE REP REPORTED THE PROCEDURE TAKING PLACE WAS AN MIS BUNION AND CHEILECTOMY. THE PATIENT WAS UNDER ANESTHESIA WHEN THE CASE WAS CANCELLED AND RESCHEDULED.

  Patient problems: No Code Available

  MAUDE report 9353240 ↗