Arthrex® AR-400SAGRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00888867223424), received between Dec 26, 2023 and Feb 27, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Defective Device” (3 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 27, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A FOOT-SURGERY AS SOON AS THE SAWING PROCESS BEGAN, THE ATTACHMENT DETACHED FROM THE HANDPIECE AND DIDN`T HOLD. 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 24470809 ↗
• MalfunctionFeb 16, 2026Use of Device Problem

  IT WAS REPORTED THAT THE DEVICE OSCILLATES BUT DOES NOT CUT ON THE MITER SAW. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED. UPDATE 9-FEB-26: MORE INFORMATION WAS PROVIDED THAT THE DEVICE DID NOT OSCILLATE APPROPRIATELY. THIS WAS DISCOVERED DURING A FOOT ARTHROSCOPY ON (B)(6) 2026. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE (AR-300 + AR-300SAG). IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24345601 ↗
• MalfunctionDec 8, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING A SURGERY ACCORDING TO AUSTIN/AKIN THE DEVICE AR-400SAG (SN: (B)(6)) COULD NOT BE INSERTED. 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 23743631 ↗
• MalfunctionJul 7, 2025Defective Device; Defective Device

  ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06922391 THAT AN AR-400SAG DRILL ATTACHMENT IS NOT FUNCTIONING PROPERLY. DISCOVERED DURING A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22414541 ↗
• MalfunctionJan 22, 2025Defective Device; Defective Device

  ON (B)(6) 2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-400SAG SAGITTAL SAW ATTACHMENT COUPLING TO THE MOTOR DOES NOT FIT PROPERLY. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21211022 ↗
• MalfunctionOct 29, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT THE BOTH DEVICES ARE DEFECTIVE AND THEY WOBBLE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THERE WAS NO CASE INVOLVEMENT REPORTED. NO FURTHER INFORMATION RECEIVED. ***UPDATE, KHE, 11-OCT-2024 FURTHER INFORMATION RECEIVED. IT WAS REPORTED THAT THE MACHINE RUNS IRREGULARLY FROM THE SAW BLADE DURING USE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. ***UPDATE, KHE, 15-OCT-2024 FURTHER INFORMATION RECEIVED. THE EVENT OCCURRED DURING A REPOSITIONING OSTEOTOMY FEMUR. NO PIECE BROKE OFF INSIDE THE PATIENT. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE CLAIMED 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 20556271 ↗
• MalfunctionSep 11, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE DEVICE AND ITS ATTACHMENT HAVE WEDGED AND CAN NO LONGER BE SEPARATED. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THERE WAS NO CASE INVOLVEMENT REPORTED. NO FURTHER INFORMATION RECEIVED. UPDATE KPILZ 05-SEP-2024: IT WAS REPORTED THAT DURING AN ACL SURGERY THE DEVICE AND ITS ATTACHMENT HAVE WEDGED AND CAN NO LONGER BE SEPARATED. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW 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 20189795 ↗
• MalfunctionAug 9, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING A CONVERSION OPEN-WEDGE OSTEOTOMY FOOT SURGERY THE AR-400SAG JAMMED AND DID NOT WORK. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE (SYNTHES COLIBRI). IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19950773 ↗
• MalfunctionJun 10, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE DEVICES DOESN`T CUT AS IT SHOULD. THE CUSTOMER EXPERIENCES HEAT DEVELOPMENT. 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 19505406 ↗
• MalfunctionMay 13, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A HALLUX VALGUS SURGERY THE DEVICE OSCILLATED TOO LITTLE, WHICH MADE THE SAW BLADE LESS EFFECTIVE AND CAUSED UNNECESSARY HEAT DURING USE. 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 19297799 ↗
• MalfunctionApr 22, 2024Overheating of Device; Overheating of Device

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS (B)(4) THAT AN AR-400SAG SAW ATTACHMENT OVERHEATED. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19151311 ↗
• MalfunctionJan 8, 2024Dull, Blunt; Dull, Blunt

  ON 12/12/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-400SAG SAW ATTACHMENT BLADE IS DULL AND WILL NOT CUT BONE. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18464610 ↗
• MalfunctionDec 26, 2023Dull, Blunt; Dull, Blunt

  ON 11/28/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06411874 THAT AN AR-400SAG DRILLSAW SPORTS 400 SYSTEM WAS NOT MOVING AS RAPIDLY AS IT SHOULD AND WOULD NOT CUT. THIS OCCURRED DURING A CASE, WITH NO EFFECT ON THE PATIENT. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18394074 ↗