Arthrex® AR-300-B201Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00888867028654), received between Feb 28, 2018 and Aug 29, 2025 — classified as 2 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Break” (22 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 29, 2025Break; Break

  ON 08/12/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-300-B201 BURR BROKE INTRAOPERATIVELY WITHOUT APPLYING SIGNIFICANT FORCE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22921095 ↗
• MalfunctionJul 30, 2025Break; Break

  ON 07/09/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-300-B201 BURR BROKE OFF INSIDE A PATIENT DURING SURGERY. THE SURGEON WAS ABLE TO REMOVE IT FROM THE PATIENT AFTER OPENING UP THE LATERAL SIDE OF THE FIRST METATARSAL AND PULLING OUT METAL PIECE. THIS OCCURRED DURING USE IN A MIS BUNION CASE.

  Patient problems: Insufficient Information

  MAUDE report 22664903 ↗
• MalfunctionJul 22, 2025Break; Break

  ON 06/30/2025, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-300-B201 BURR BROKE OFF. THERE WAS A SLIGHT DELAY RETRIEVING THE PIECES BUT ALL PIECES WERE RETRIEVED, AND THE CASE WAS COMPLETELY SUCCESSFULLY WITH NO PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED, ON 7/3/25, INDICATING NO ADDITIONAL ANESTHESIA WAS USED. THE FIRST BURR BROKE DURING AN MIS BUNION AND THE SECOND DURING DMMOS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22567781 ↗
• MalfunctionJul 22, 2025Break; Break

  ON 06/30/2025, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-300-B201 BURR BROKE OFF. THERE WAS A SLIGHT DELAY RETRIEVING THE PIECES BUT ALL PIECES WERE RETRIEVED, AND THE CASE WAS COMPLETELY SUCCESSFULLY WITH NO PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED 7/3/25 INDICATING NO ADDITIONAL ANESTHESIA WAS USED. THE FIRST BURR BROKE DURING AN MIS BUNION AND THE SECOND DURING DMMOS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22567765 ↗
• MalfunctionJul 21, 2025Break; Break

  ON 06/26/2025, A SALES REPRESENTATIVE VIA PHONE THAT (2) AR-300-B201 BURRS BROKE. THIS OCCURRED DURING A CHEILECTOMY PROCEDURE ON (B)(6) 2025 WHILE SHAVING THE FIRST BURR SNAPPED, THE FRAGMENT WAS REMOVED AND THE SECOND ONE WAS ATTEMPTED WHICH ALSO BROKE. THE FRAGMENTS WERE RETRIEVED AND THE CASE PROCEEDED USING AN AR-300-B202. THIS RESULTED IN A 12-15 MINUTE DELAY IN WHICH IT IS UNSURE IF ADDITIONAL ANESTHESIA WAS ADMINISTERED. THERE WAS NO HARM ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22554774 ↗
• MalfunctionJul 21, 2025Break; Break

  ON (B)(4) 2025, A SALES REPRESENTATIVE VIA PHONE THAT (2) AR-300-B201 BURRS BROKE. THIS OCCURRED DURING A CHEILECTOMY PROCEDURE ON (B)(6) 2025 WHILE SHAVING THE FIRST BURR SNAPPED, THE FRAGMENT WAS REMOVED AND THE SECOND ONE WAS ATTEMPTED WHICH ALSO BROKE. THE FRAGMENTS WERE RETRIEVED AND THE CASE PROCEEDED USING AN AR-300-B202. THIS RESULTED IN A 12-15 MINUTE DELAY IN WHICH IT IS UNSURE IF ADDITIONAL ANESTHESIA WAS ADMINISTERED. THERE WAS NO HARM ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22554773 ↗
• MalfunctionJul 17, 2025Break; Break

  ON 06/20/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-300-B201 BURR BROKE AT THE BASE IMMEDIATELY AFTER USE. BROKEN FRAGMENTS HAVE BEEN REMOVED. THIS CASE WAS COMPLETED BY USING ANOTHER PRODUCT OF SAME PRODUCT NUMBER. THIS OCCURRED DURING USE IN A OSTEOTOMY OF THE DISTAL METATARSAL BONE IN HALLUX VALGUS SURGERY CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22531612 ↗
• MalfunctionMar 13, 2025Break; Break

  ON (B)(6) 2025, IT WAS REPORTED BY A ARTHREX EMPLOYEE VIA EMAIL THAT FOR AR-300-B201, BURR, STRAIGHT, 19.5 MM, DIAM. 2.0 MM, THE BURR BROKE OFF. THIS WAS DISCOVERED DURING A BILATERAL MICA ON (B)(6) 2025. THE CASE WAS COMPLETED SUCCESSFULLY BY USING A NEW AR-300-B201. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21596831 ↗
• MalfunctionJan 13, 2025Break; Break

  ON 12/16/2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-300-B201 BURR BROKE DURING THE CASE. THE BURR WAS PULLED OUT WITH A NEEDLE DRIVER. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21137527 ↗
• MalfunctionSep 27, 2024Break; Break

  ON 09/20/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-300-B201 BURR HAD THE TIP BREAK OFF DURING A CASE. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20320290 ↗
• MalfunctionSep 13, 2024Break; Break

  IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06648728 THAT AN AR-300-B201 BURR BROKE IN HALF IN TWO PIECES WHEN THE SURGEON WAS TRYING TO GET THE BURR AS DISTAL AS POSSIBLE DURING THE LAST PASS OF THE BURR. THE SURGEON IMMEDIATELY REMOVED THE REMAINING BURR AND HANDPIECE AS WELL AS RETRIEVED THE BROKEN PART OF THE BURR FROM THE PATIENT. AN X-RAY WAS UTILIZED TO CONFIRM ALL PIECES OF THE BURR WERE REMOVED FROM THE PATIENT. NO PATIENT HARM WAS CAUSED, AND THERE WAS NO DELAY IN THE SURGERY DUE TO THIS EVENT. THE SURGEON WAS ABLE TO FINISH SURGERY WITHOUT NEEDING TO OPEN ANOTHER BURR. THERE WAS NO DAMAGE CAUSED TO THE MIS HANDPIECE, AND THE REMAINING PIECE OF THE BURR WAS REMOVED FROM THE DEVICE. THIS WAS DISCOVERED DURING AN MIS HAGLUNDS REMOVAL PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20213224 ↗
• MalfunctionJun 6, 2024Break; Break

  ON 5/10/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06564363 THAT AN AR-300-B201 BURR INSTRUMENT BROKE DURING THE CASE. THE PATIENT WAS NOT AFFECTED AND THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19477884 ↗
• MalfunctionMay 24, 2024Break; Break

  ON 4/26/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06550273 THAT AN AR-300-B201 BURR BROKE ABOUT 5MM FROM THE BASE WHERE IT INSERTS INTO THE HANDPIECE (INSIDE ON THE HANDPIECE) OF AN AR-200M MOTOR WITH CABLE DURING THE CASE. THEY WERE UNABLE TO GET IT OUT OF THE HANDPIECE. THIS EVENT OCCURRED INSIDE THE PATIENT'S FOOT DURING A MIDFOOT FUSION PROCEDURE, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19393345 ↗
• MalfunctionApr 22, 2024Break; Break

  ON 3/27/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-300-B201 STRAIGHT BURR TIP BROKE OFF. ANOTHER AR-300-B201 FROM A DIFFERENT LOT NUMBER WAS USED TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING A MIS BUNION PROCEDURE ON (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 19154650 ↗
• MalfunctionJun 22, 2023Break; Break

  ON 06/01/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-300-B201 BURR BROKE. THIS OCCURRED DURING A CASE WHILE CUTTING THE DEVICE BROKE. A FRAGMENT ENTERED THE PATIENT AND WAS RETRIEVED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT EFFECT REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17181997 ↗
• InjuryDec 27, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN MIS HAND PIECE BROKE, AND CASE WAS UNABLE TO BE PERFORMED ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2022: THIS WAS DISCOVERED DURING AN AKIN PROCEDURE ON (B)(6) 2022. AN AR-300-B201 BURR AND AN OEM04364100 IRRIGATION TUBING BROKE, AND THE CASE HAD TO BE ABORTED. THIS WAS BEFORE THE CASE STARTED; HOWEVER, THE PATIENT WAS ALREADY UNDER ANESTHESIA. AS OF NOW, PROCEDURE HAS NOT BEEN RESCHEDULED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16051574 ↗
• MalfunctionDec 6, 2022Break

  IT WAS REPORTED THAT DURING A SURGERY THE SURGEON HAD A STRANGE SENSATION FROM THE FIRST SECONDS WITH GREAT DIFFICULTY IN THE BONE RESECTION. THE BURR THEN BROKE IN THE PATIENT. ALL BROKEN PARTS WERE RETRIEVED FROM THE PATIENT. 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 15923904 ↗
• MalfunctionJul 5, 2022Break

  IT WAS REPORTED THAT DURING A MIS FOOT SURGERY THE DEVICE BROKE INSIDE THE PATIENT. ALL BROKEN PARTS WERE RETRIEVED FROM THE PATIENT. 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 14914736 ↗
• MalfunctionFeb 28, 2022Break

  ON 12/01/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-300-B201 BURR BROKE DURING USE ON CALCANEUS. THIS WAS DISCOVERED DURING USE WITH NO IMPACT OR INJURY TO THE PATIENT, THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13620099 ↗
• MalfunctionMar 12, 2021Break

  IT WAS REPORTED THAT THE DEVICE BROKE DURING A HALLUS VALGUS FOOT ARTHROSCOPY SURGERY INSIDE THE PATIENT. THIS HAPPENED TWICE DURING THE SAME SURGERY AND THESE BREAKS WERE SHARP AT THE BASE OF THE CUTTER HEADS. FURTHER APPROACHES HAD TO BE CREATED ON THE PATIENT TO RETRIEVE THE HEADS OF THE DEVICES. 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 DO A SECOND SURGERY. UPDATE 26-FEB-2021: THE LOT NUMBER 022206 WAS PROVIDED AND WAS UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11472362 ↗
• MalfunctionMar 8, 2021Break

  IT WAS REPORTED THAT THE DEVICE BROKE DURING A HALLUS VALGUS FOOT ARTHROSCOPY SURGERY INSIDE THE PATIENT. THIS BREAK WAS SHARP AT THE BASE OF THE CUTTER HEAD. FURTHER APPROACHES HAD TO BE CREATED ON THE PATIENT TO RETRIEVE THE HEAD OF 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 DO A SECOND SURGERY. UPDATE 26-FEB-2021: THE LOT NUMBER 022206 WAS PROVIDED AND WAS CORRECTED IN THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11436698 ↗
• InjuryFeb 28, 2018Break

  IT WAS REPORTED THAT DURING SURGERY THE BURR BROKE. BECAUSE OF THAT INCIDENT THE SURGEON HAD TO SWITCH TO AN OPEN TECHNIQUE AND WAS USING THE SAW. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH THE SAW. THERE WAS NO HARM FOR PATIENT, USER OR THIRD PARTY. FOLLOW-UP INVESTIGATION: THE TIP OF BURR BROKE AND WAS NOT RETRIEVED. THE TIP WILL REMAIN INSIDE THE DRILL HOLE WHICH IS SECURED BY A TITAN ANCHOR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7302197 ↗