Arthrex® AR-300Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00888867099357), received between Dec 2, 2016 and Jun 20, 2024 — classified as 3 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (8 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 20, 2024Overheating of Device; Overheating of Device

  ON 06/22/2022, IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS THAT AN AR-300 HANDPIECE WAS USED IN A MICROSURGERY ON (B)(6) 2022 WHEN ASSEMBLING THE BATTERY HOUSING WITH THE POWER DRILL HANDPIECE AND PRESSING, THE MOTOR IS NOT RUNNING. AT THE SAME TIME, THE BATTERY AND THE BATTERY HOUSING OVERHEATED. THE CASE WAS COMPLETED USING ANOTHER HANDPIECE, AND THERE WAS NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19574082 ↗
• MalfunctionMay 24, 2024Break; Break

  IT WAS REPORTED THAT THE PIN IS LOOSE. 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 19397452 ↗
• MalfunctionMay 24, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE DEVICE HEATS UP AND SHOWS A DROP IN PERFORMANCE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19390491 ↗
• MalfunctionMay 23, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT THE LOCKING SCREW LOOSENS DURING OSCILLATING SAWING, SO THAT THE SAW BLADE LOOSENS UNDER PRESSURE LOAD. 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 19381390 ↗
• MalfunctionMay 22, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE DEVICE IS HEATING AND HAS NO POWER. 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 19372426 ↗
• MalfunctionMay 17, 2024Break; Break

  IT WAS REPORTED THAT THE PINS BROKE. THE PROBLEM WAS NOTICED AFTER THE SURGERY. THERE WAS NO HARM FOR THE PATIENT, OPERATOR OR THIRD PARTY REPORTED. THERE WAS NO CASE INVOLVEMENT REPORTED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19345734 ↗
• MalfunctionMay 1, 2024Break; Break

  IT WAS REPORTED THAT THE DEVICE HAS A BROKEN BATTERY PIN. THE PROBLEM WAS NOTICED AFTER SURGERY. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THERE WAS NO CASE INVOLVEMENT REPORTED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19219746 ↗
• MalfunctionApr 5, 2024Break; Break

  IT WAS REPORTED THAT A CONTACT PIN OF THE DEVICE IS BROKEN OFF. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THERE WAS NO CASE INVOLVEMENT REPORTED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19051152 ↗
• MalfunctionMar 15, 2024Overheating of Device; Overheating of Device

  ON 03/01/2024, IT WAS REPORTED BY A ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-300 DRILL WAS CAUSING A BURNING SMELL. THIS OCCURRED BEFORE USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18915767 ↗
• MalfunctionJan 22, 2024Break; Break

  IT WAS REPORTED THAT DURING A SURGERY THE DRILL CHUCK HOLDER OF AR-300DJ BROKE OFF AND THE PIN TO THE BATTERY OF AR-300 BROKE OFF OUTSIDE OF THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY AND THE SAME DEVICE WAS USED ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18552320 ↗
• MalfunctionOct 27, 2023Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT THE DEVICE RUNS HOT. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED. UPDATE AVOE 25-OCT-2023, FURTHER INFORMATION WAS PROVIDED THAT 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 DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18023084 ↗
• MalfunctionOct 26, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE MOTOR OVERHEATS. THE PROBLEM WAS NOTICED AFTER THE SURGERY. THERE WAS NO HARM FOR THE PATIENT, OPERATOR OR THIRD PARTY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18011906 ↗
• InjuryOct 13, 2023Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  ON 9/19/2023, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA SEMS-06035848 AND SEMS-06046595 THAT AN AR-300 HANDPIECE HAD AN ISSUE. AT THE BEGINNING OF THE SURGERY ON 9/6/2023, THEY TESTED THE PERFORATOR, WHICH WAS WORKING NORMALLY, HOWEVER, DURING THE PROCEDURE, WHEN THEY WENT TO USE IT, IT MALFUNCTIONED. THEY DID ALL THE TESTS POSSIBLE, AND IT DIDN'T WORK. THEY CLOSED THE SURGERY DUE TO A LACK OF MATERIAL, AND IT WILL BE RESCHEDULED. THIS OCCURRED DURING USE IN AN UNSPECIFIED PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON 9/22/2023, THE ARTHREX SUBSIDIARY EMPLOYEE PROVIDED THE FOLLOWING INFORMATION VIA EMAIL: THIS OCCURRED DURING A FOOT SURGERY PROCEDURE FOR A CHONDRAL INJURY ON (B)(6) 2023. A SCRUB NURSE WAS PRESENT DURING THE CASE. THERE WAS NO ACCESSORY ATTACHED TO THE DRILL, JUST THE ENGINE.

  Patient problems: Insufficient Information

  MAUDE report 17932446 ↗
• MalfunctionSep 11, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A CHEVRON FOOT SURGERY THE DEVICE MADE MORE/UNUSUAL NOISE AND GOT HOT DURING USE. 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 17720943 ↗
• MalfunctionSep 11, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A CHEVRON FOOT SURGERY THE DEVICE MADE MORE/UNUSUAL NOISE AND GOT HOT DURING USE. 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 17719147 ↗
• MalfunctionAug 3, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE DEVICE WAS USED IN SEVERAL SURGERIES AND ALWAYS GOT TOO HOT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERIES WERE FINISHED SUCCESSFULLY WITH THE SAME 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 17451528 ↗
• MalfunctionJan 24, 2022Output Problem

  IT WAS REPORTED THAT THE DEVICE REFUSES TO WORK, WHEN PRESSURE IS APPLIED TO THE DEVICE. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED. UPDATE 10-JAN-2022: IT WAS CONFIRMED THAT THE ERROR OCCURRED DURING AN OPEN REPOSITIONING AND PLATING OF A RADIUS FRACTURE SURGERY. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE. IT WAS NOT NECESSARY TO DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13333993 ↗
• InjuryMay 6, 2020Defective Component

  IT WAS REPORTED THAT DURING A HALLUX VALGUS OSTEOTOMY THE HANDPIECE DID NOT WORK. PUSHING THE TRIGGER DID NOT LEAD TO MOTOR MOVEMENT. IT WAS FURTHER REPORTED THAT LIQUID WAS GOING OUT OF THE TRIGGER POINT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED. UPDATE 14-APR-2020: FURTHER INFORMATION WAS PROVIDED THAT THE REPORTED EVENT WAS IDENTIFIED AT THE START OF THE SURGERY. THE PATIENT WAS ALREADY IN PLACE AND UNDER PROPER ANESTHESIA. BEFORE THE FIRST CUT WAS MADE IT WAS FOUND THAT THE TRIGGER OF THE DEVICE DID NOT WORK AND AS THE CUSTOMER HAS NO BACKUP DEVICE THE SURGERY WAS STOPPED AND POSTPONED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10028206 ↗
• InjuryDec 2, 2016Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING THE SURGERY THE AR-300 CAN´T SAW THE CALCANEUS BONE, THE SURGEON TRIED IN TOTAL 3 HAND PIECES WITHOUT SUCCESS. AFTER 30 MINUTES, THE SURGEON SWITCHED TO AN OPEN PROCEDURE. THE SURGERY TOOK 60 MINUTES MORE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6140664 ↗