Arthrex® AR-600SAGRecalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00888867111073), received between Oct 6, 2023 and Feb 2, 2026 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (6 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 2, 2026Use of Device Problem

  IT WAS REPORTED THAT THE DEVICE IS DEFECTIVE. ALSO, THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. IT WILL BE PROCESSED AS REPAIR, NOT AS COMPLAINT. UPDATE 14-JAN-2026 - FURTHER INFORMATION WAS RECEIVED: IT WAS REPORTED THAT DURING A SURGERY, THE SAW ATTACHMENT STOPS AS SOON AS IT IS PLACED ON THE BONE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. UPDATE 15-JAN-2026 - FURTHER INFORMATION WAS RECEIVED: IT WAS REPORTED THAT DURING THE HIP PROTHESIS SURGERY, THE SAW ATTACHMENT STOPS AS SOON AS IT IS PLACED ON THE BONE. 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 24232624 ↗
• MalfunctionDec 4, 2024Positioning Failure; Detachment of Device or Device Component; Positioning Failure; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SAW ATTACHMENT IS DEFECTIVE, THE SAW BLADE DOES NOT HOLD IN THE ANCHORAGE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THERE WAS NO CASE INVOLVEMENT REPORTED. NO FURTHER INFORMATION RECEIVED. UPDATE, KHE, 26-NOV-2026 FURTHER INFORMATION RECEIVED WITH A COMPLAINT FORM. THE EVENT OCCURRED DURING A SHOULDER PROSTHESIS. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO PIECE BROKE OFF INSIDE THE PATIENT. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NO. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20842621 ↗
• MalfunctionAug 7, 2024Loss of Power; Loss of Power

  IT WAS REPORTED THAT THE DEVICE WORKED IN IDLE MODE BUT STOPPED ON BONE CONTACT. NO FURTHER INFORMATION RECEIVED. UPDATE KPILZ 06-AUG-2024: THE FAILURE OCCURRED DURING A SURGERY. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW SAWBLADE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19930427 ↗
• MalfunctionJul 9, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE SAW BLADE CAN´T BE PULLED OUT. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19701648 ↗
• MalfunctionJun 18, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT THE DEVICE STUCK AND HAS VIBRATES. THIS WAS NOTICED DURING THE KNEE PROSTHESIS SURGERY. THERE WAS NO HARM 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 SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19559460 ↗
• MalfunctionJun 14, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A KNEE ENDOPROSTHESIS THE DEVICE STOPPED SAWING AS SOON AS IT HIT THE BONE. IT WAS FURTHER REPORTED THAT THE DEVICE VIBRATED AND OVERHEATED. THERE WAS NO HARM 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 SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19535541 ↗
• MalfunctionJun 10, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN AMPUTATION, THE AR-600SAG, WOULD NOT WORK WHEN TRYING TO CUT FIBULA AS THE PINS OF THE BASE THAT CONNECTS TO THE DRILL FALL OUT AND CAN NO LONGER BE USED. ANOTHER HANDPIECE WAS USED IN ORDER TO COMPLETE THE CASE WITHOUT FURTHER ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19497712 ↗
• MalfunctionJun 10, 2024Defective Device; Defective Device

  ON 03/08/2023, IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS THAT AN AR-600SAG SAW ATTACHMENT IS OSCILLATING WITH A VIBRATION. THIS OCCURRED DURING A CASE ON 03/01/2023, CREATING IMPERFECT CUTS. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19497141 ↗
• MalfunctionMay 24, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING A KNEE TEP SURGERY THE BLADE BECAME STUCK IN THE BONE AND DID NOT CUT ANYMORE. THE SURGEON REPORTED THAT 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 19395324 ↗
• MalfunctionApr 30, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT DURING A KNEE-TEP SURGERY THE DEVICE VIBRATED AND GOT STUCK IN THE BONE WITHOUT SAWING. NO PART OF THE DEVICE BROKE OFF. 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 19212753 ↗
• MalfunctionApr 30, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING KNEE PROTHESIS SURGERY THE SAWBLADE GOT STOCK, IS VIBRATING AND IS GETTING HOT. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE USED ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19211573 ↗
• MalfunctionApr 23, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A TOTAL KNEE PROSTHESIS SURGERY THE SAW ATTACHMENT FAILED. IT WAS REPORTED THAT THE ATTACHMENTS STARTED TO VIBRATE, GOT TO HOT AND THEN THE BLADE GOT STUCK. THERE WAS NO HARM 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 SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19166463 ↗
• MalfunctionApr 23, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A TOTAL KNEE PROSTHESIS SURGERY THE SAW ATTACHMENT FAILED. IT WAS REPORTED THAT THE ATTACHMENTS STARTED TO VIBRATE, GOT TO HOT AND THEN THE BLADE GOT STUCK. THERE WAS NO HARM 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 SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19166280 ↗
• MalfunctionApr 23, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A TOTAL KNEE PROSTHESIS SURGERY THE SAW ATTACHMENTS FAILED. IT WAS REPORTED THAT THE ATTACHMENTS STARTED TO VIBRATE, GOT TO HOT AND THEN THE BLADE GOT STUCK. THERE WAS NO HARM 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 SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19165996 ↗
• MalfunctionApr 23, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A TOTAL KNEE PROSTHESIS SURGERY THE SAW ATTACHMENTS FAILED. IT WAS REPORTED THAT THE ATTACHMENTS STARTED TO VIBRATE, GOT TO HOT AND THEN THE BLADE GOT STUCK. THERE WAS NO HARM 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 SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19165909 ↗
• MalfunctionApr 23, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A TOTAL KNEE PROSTHESIS SURGERY MULTIPLE SAW ATTACHMENTS FAILED. IT WAS REPORTED THAT THE ATTACHMENTS STARTED TO VIBRATE, GOT TO HOT AND THEN THE BLADE GOT STUCK. THERE WAS NO HARM 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 SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19165793 ↗
• MalfunctionApr 23, 2024Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING A TOTAL KNEE PROSTHESIS SURGERY THE SAW ATTACHMENTS FAILED. IT WAS REPORTED THAT THE ATTACHMENTS STARTED TO VIBRATE, GOT TO HOT AND THEN THE BLADE GOT STUCK. THERE WAS NO HARM 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 SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19165635 ↗
• MalfunctionApr 23, 2024Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING A TOTAL KNEE PROSTHESIS SURGERY MULTIPLE THE ATTACHMENTS FAILED. IT WAS REPORTED THAT THE ATTACHMENTS STARTED TO VIBRATE, GOT TO HOT AND THEN THE BLADE GOT STUCK. THERE WAS NO HARM 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 SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19165512 ↗
• MalfunctionApr 23, 2024Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING A TOTAL KNEE PROSTHESIS SURGERY MULTIPLE SAW ATTACHMENTS FAILED. IT WAS REPORTED THAT THE ATTACHMENTS STARTED TO VIBRATE, GOT TO HOT AND THEN THE BLADE GOT STUCK. THERE WAS NO HARM 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 SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19165323 ↗
• MalfunctionMar 5, 2024Failure to Cut; Failure to Cut

  ADDITIONAL INFORMATION WAS PROVIDED ON 02/20/2024, WHERE IT WAS REPORTED THAT THIS EVENT OCCURRED DURING A HIP SURGERY ON (B)(6) 2024. THE CASE WAS COMPLETED USING A NON-ARTHREX DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18836288 ↗
• MalfunctionMar 5, 2024Failure to Cut; Failure to Cut

  ON 02/16/2024, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT AN AR-600SAG SAW ATTACHMENT SAGITTAL STOPS WHEN CUTTING. THIS OCCURRED DURING A CASE, WITH NO EFFECT ON THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18835726 ↗
• MalfunctionDec 20, 2023Break; Break

  IT WAS REPORTED THAT DURING A KNEE PROSTHETIC THE SMALL SPLEEN THAT KEEPS THE SAW ATTACHMENT FROM ROTATING THE BLADE BROKE OFF OR FELL OUT DURING THE PROCEDURE. IT WAS FURTHER REPORTED THAT THE SPLEEN COULD NOT BE FOUND AFTER THE PROCEDURE BUT THE CUSTOMER IS CERTAIN THAT IT DID NOT FALL INTO THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGEON DECIDED TO CONTINUE TO USE THE DEVICE AND FINISHED THE SURGERY SUCCESSFULLY WITH THE SAME DEVICE, BUT DUE TO THE MISSING SPLEEN, THE DEVICE HAD TO BE USED WITH CAUTION. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18363065 ↗
• MalfunctionOct 12, 2023Use of Device Problem; Dull, Blunt; Use of Device Problem; Dull, Blunt

  IT WAS REPORTED THAT DURING A KNEE ARTHROPLASTY, WHEN THE SAW BLADE MET HARD BONE, IT SORT OF DANCED ON THE BONE INSTEAD OF CUTTING INTO THE BONE. THE MACHINE TURNED UP THE POWER BUT IT DIDN¿T CUT. 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 SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17921879 ↗
• MalfunctionOct 6, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A HIP PROTHESIS SURGERY WHEN CUTTING THE FEMORAL NECK, THE SAW BLADE GET STUCK IN THE BONE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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 17889901 ↗