Arthrex® AR-600Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00888867110175), received between Jun 23, 2020 and Jul 27, 2026 — classified as 1 injury, 18 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (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. 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.

• MalfunctionJul 27, 2026Overheating of Device; Unexpected Shutdown

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50011858 ↗
• MalfunctionFeb 5, 2026Overheating of Device

  IT WAS REPORTED THAT DURING A SURGERY, THE DEVICE BECOMES HOT DURING SAWING. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. FURTHER INFORMATION HAS BEEN REQUESTED. UPDATE ON 19-JAN-2026 - FURTHER INFORMATION WAS RECEIVED: IT WAS REPORTED THAT DURING THE HIP JOINT ENDOPROSTHESIS SURGERY, THE DEVICE BECOMES HOT DURING SAWING. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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 24267494 ↗
• MalfunctionSep 24, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A CRUCIATE LIGAMENT SURGERY THE DEVICE BECAME HOT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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 20289857 ↗
• MalfunctionJun 18, 2024Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT THE DEVICE GETS HOT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED. FURTHER QUESTIONS WILL BE ASKED. ***UPDATE 11-NOV-2021 THE CUSTOMER REPORTED ADDITIONALLY THAT THE PROBLEM WAS NOTICED DURING THE SURGERY. THE PERFORMANCE WAS NOTICEABLY WEAKER AND THEN STOPPED. THE ENGINE WAS EXTREMELY HOT, EVEN WITH COOLING IN THE FORM OF A WET TOWEL. THE MACHINE WAS REPLACED DURING THE SURGERY. THE PATIENT OR OTHER PERSONS WERE NOT HARMED, AND APART FROM THE SAW THERE WAS NO DAMAGE AT ALL. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO NEED TO SWITCH TO ANOTHER SURGICAL TECHNIQUE. NO SECOND SURGERY WAS NECESSARY. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19559509 ↗
• MalfunctionJun 18, 2024Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT DURING A SURGERY THE BACK PART OF THE DEVICE BECAME HOT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THIS WAS NOTICED BEFORE THE SURGERY. NO FURTHER INFORMATION RECEIVED. UPDATE AVOE 11-APR-2022: IT WAS CONFIRMED THAT THE ERROR OCCURRED ON THE (B)(6) 2022 DURING A HIP SURGERY. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19559072 ↗
• MalfunctionJun 14, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY DUE TO OVERHEAT OF THE MOTOR WHILE USING OF THE SAW ATTACHMENT THE DRILL STOPPED WHEN CUTTING THE BONE. 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 19538918 ↗
• MalfunctionJun 14, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY DUE TO OVERHEAT OF THE MOTOR WHILE USING OF THE SAW ATTACHMENT THE DRILL STOPPED WHEN CUTTING THE BONE. 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 19538850 ↗
• MalfunctionJun 13, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY DUE TO OVERHEAT OF THE MOTOR WHILE USING OF THE SAW ATTACHMENT THE DRILL STOPPED WHEN CUTTING THE BONE. 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 19528554 ↗
• MalfunctionJun 13, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPIC PROCEDURE, THE AR-600 STOPPED WORKING AND LATER HEATED UP. THE AR-600RZH ALSO WOULD NOT GRIP INSIDE THE HANDPIECE. THE CASE WAS COMPLETED BY USING A NEW AR-600 AND A NEW AR-600RZH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19526656 ↗
• MalfunctionJun 10, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY DUE TO OVERHEAT OF THE MOTOR WHILE USING OF THE SAW ATTACHMENT THE DRILL STOPPED WHEN CUTTING THE BONE. 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 19497963 ↗
• MalfunctionJun 10, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY DUE TO OVERHEAT OF THE MOTOR WHILE USING OF THE SAW ATTACHMENT THE DRILL STOPPED WHEN CUTTING THE BONE. 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 19497926 ↗
• MalfunctionJun 10, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY DUE TO OVERHEAT OF THE MOTOR WHILE USING OF THE SAW ATTACHMENT THE DRILL STOPPED WHEN CUTTING THE BONE. 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 19497838 ↗
• MalfunctionMay 22, 2024Intermittent Loss of Power; Intermittent Loss of Power

  IT WAS REPORTED THAT DURING SURGERIES OVER AN EXTENDED PERIOD OF TIME EXPERIENCED LACK OF POWER IN THE MACHINE. THIS WAS ESPECIALLY NOTICED DURING TOTAL KNEE REPLACEMENT PROCEDURES WHERE A LOT OF SAWING POWER IS NEEDED. IT WAS FURTHER REPORTED THAT THE BLADE GOT STUCK IN THE BONE DUE TO THIS FAILURE AND THE SURGEON HAD TO APPLY MUCH FORCE TO BE ABLE TO SAW AND IT STILL WENT VERY SLOWLY. THE CUSTOMER HAS REPLACED THE ATTACHMENT CHUCK TO RESOLVE THE REPORTED ISSUE WITHOUT SUCCESS. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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 19372217 ↗
• MalfunctionMay 22, 2024Intermittent Loss of Power; Intermittent Loss of Power

  IT WAS REPORTED THAT DURING SURGERIES OVER AN EXTENDED PERIOD OF TIME EXPERIENCED LACK OF POWER IN THE MACHINE. THIS WAS ESPECIALLY NOTICED DURING TOTAL KNEE REPLACEMENT PROCEDURES WHERE A LOT OF SAWING POWER IS NEEDED. IT WAS FURTHER REPORTED THAT THE BLADE GOT STUCK IN THE BONE DUE TO THIS FAILURE AND THE SURGEON HAD TO APPLY MUCH FORCE TO BE ABLE TO SAW AND IT STILL WENT VERY SLOWLY. THE CUSTOMER HAS REPLACED THE ATTACHMENT CHUCK TO RESOLVE THE REPORTED ISSUE WITHOUT SUCCESS. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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 19370272 ↗
• MalfunctionNov 6, 2023Break; Break

  IT WAS REPORTED THAT THE BATTERY HOLDER 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 18075097 ↗
• MalfunctionNov 6, 2023Overheating of Device; Overheating of Device

  ON 10/9/2023, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT AN AR-600 ARTHREX AR-600, HANDPIECE WAS OVERHEATING AND WILL NOT TURN ON. THE CASE WAS COMPLETED SUCCESSFULLY WITH ANOTHER AR-600 ARTHREX AR-600, HANDPIECE. THIS WAS DISCOVERED DURING A LCA PROCEDURE ON (B)(6) 2023, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18073832 ↗
• MalfunctionSep 19, 2023Defective Device; Intermittent Loss of Power; Defective Device; Intermittent Loss of Power

  IT WAS REPORTED THAT THE DEVICE STOPS SPORADICALLY. THE PROBLEM WAS NOTICED BEFORE THE SURGERY. THERE WAS NO HARM FOR THE PATIENT, OPERATOR OR THIRD PARTY REPORTED. UPDATE AVOE 29-AUG-2023. IT WAS CONFIRMED THAT THE ERROR OCCURRED DURING A ENDOPROSTHETIC JOINT REPLACEMENT SURGERY. THE ERROR LED TO AN INCREASED SURGERY TIME. 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 17775573 ↗
• MalfunctionDec 7, 2021Overheating of Device

  IT WAS REPORTED THAT DURING A KNEE SURGERY THE DEVICE SUDDENLY OVERHEATED AND TOTALLY STOPPED WORKING WHEN THE DEVICE WAS USED DURING THE INSERTION OF AN UNIKNEE PROTHESIS. THE HANDLE WAS TOO HOT TO KEEP IT IN HANDS. THE SURGEON HAD TO CHANGE TO AN OLD HALL DRILL TO FINISH THE SURGERY, THE DRILL HAVEN¿T BEEN TRIED AFTER IT WAS COOLED DOWN. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12953362 ↗
• InjuryJun 23, 2020Break

  IT WAS REPORTED THAT DURING A HUMERUS OSTEOSYNTHESIS PROCEDURE, WHEN THE SURGEON WAS TAKING OFF THE BATTERY HOUSING, AR-600LBH, OFF OF THE HANDPIECE, AR-600, HE ACCIDENTALLY ACTIVATED THE HANDPIECE, INJURING HIS THUMB. DUE TO THIS INJURY, THE SURGEON THEN DROPPED THE HANDPIECE AND BROKE THE AR-600LBH. THE SURGEON WAS ATTENDED TO AND THE CASE WAS COMPLETED WITHOUT ANY ADVERSE EFFECT TO THE PATIENT, AS A NEW HANDPIECE WAS USED.

  Patient problems: Injury

  MAUDE report 10184293 ↗