NA TN40RFLRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00613994776259), received between Nov 16, 2018 and Dec 23, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Separation” (3 reports).

3 other recalls cover devices cleared under the same FDA submission (K081475); they may or may not involve this specific model.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 23, 2025Break; Break

  IT WAS REPORTED THAT INTRA-OP, THE BALL TIP ON END OF THE DRILL BIT BROKE OFF WHILE  THE DEVICE WAS BEING USED. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23883582 ↗
• MalfunctionJul 19, 2022Break; Break

  IT WAS REPORTED THAT DURING THE RESECTION SURGERY OF A PITUITARY THE BUR BROKE WHILE THE ADENOMA WAS BEING DISSECTED. THE BUR HAD CONTACT WITH PATIENT. THE SHAFT BROKE RIGHT WHERE THE HEAD BEGINS. PIECES CAME IN CONTACT WITH THE PATIENT, AND THEY WERE REMOVED WITHOUT INCONVENIENCE WITH THE HELP OF SOME SURGICAL FORCEPS TO REACH THE MATERIAL. NO EXTRA MEDICAL INTERVENTION WAS NECESSARY TO REMOVE THE MATERIAL. NO BROKEN PIECES OF THE REPORTED PRODUCT REMAIN INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT(S). THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15054363 ↗
• MalfunctionFeb 26, 2019Material Separation; Material Separation

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE BUR HEAD BROKE DURING A TRANSFORNICIAL SURGERY. T HE HEAD OF THE BUR WAS RECOVERED FROM THE PATIENT AND NO PART WAS LEFT INSIDE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED, THOUGH THERE WAS A SLIGHT DELAY AS THE BUR WAS REGAINED FROM THE PATIENT. ANOTHER BUR WAS USED AS BACK UP DEVICE. THERE WAS NO ADDITIONAL, NON- ROUTINE ACTIONS TAKEN. THERE WAS NO PATIENT IMPACT OR INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8371212 ↗
• MalfunctionNov 16, 2018Material Separation; Mechanical Jam; Material Separation; Mechanical Jam

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT TWO (2) BURS FAILED DURING A MICRODISSECTOMY PROCEDURE. THE DEVICE WAS CONNECTED TO THE HANDPIECE, TESTED AND WAS NOT TURNING. THE BUR WAS DETACHED FROM THE UNIT WHERE IT SHOULD BE A SEALED UNIT FROM MANUFACTURING WHICH MEANS BOTH BURS SHOULD NOT BE ABLE TO PULL OUT. THE HCP NOTED THAT THE DEVICES DID NOT BREAK AND THE BURS WERE PREPARED CORRECTLY ACCORDING TO THE DIRECTIONS GIVEN IN THE PRODUCT MANUAL. THE HCP CONFIRMED THAT IT WAS THE INITIAL USE OF THE DEVICES AND THERE WAS NO TROUBLESHOOTING POSSIBLE AS BOTH ARE DISPOSABLE DEVICES. THERE WAS A DELAY IN THE PROCEDURE DUE TO OPENING OF THE SECOND BUR AND CHANGING OF ATTACHMENT. A BACK-UP DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT OR INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8078612 ↗
• MalfunctionNov 16, 2018Material Separation; Mechanical Jam; Material Separation; Mechanical Jam

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT TWO (2) BURS FAILED DURING A MICRODISSECTOMY PROCEDURE. THE DEVICE WAS CONNECTED TO THE HANDPIECE, TESTED AND WAS NOT TURNING. THE BUR WAS DETACHED FROM THE UNIT WHERE IT SHOULD BE A SEALED UNIT FROM MANUFACTURING WHICH MEANS BOTH BURS SHOULD NOT BE ABLE TO PULL OUT. THE HCP NOTED THAT THE DEVICES DID NOT BREAK AND THE BURS WERE PREPARED CORRECTLY ACCORDING TO THE DIRECTIONS GIVEN IN THE PRODUCT MANUAL. THE HCP CONFIRMED THAT IT WAS THE INITIAL USE OF THE DEVICES AND THERE WAS NO TROUBLESHOOTING POSSIBLE AS BOTH ARE DISPOSABLE DEVICES. THERE WAS A DELAY IN THE PROCEDURE DUE TO OPENING OF THE SECOND BUR AND CHANGING OF ATTACHMENT. A BACK-UP DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT OR INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8077880 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K081475. One submission often covers many models, so check the product and lot details in each record.

• Z-0961-2022 · Dec 15, 2021 · Terminated
  Software 1898072 IPC upgrade v 2.7.3.0, IPC System: a) CONSOLE 1898001 IPC, Product Number 1898001; b) CONSOLE IPC REFURB, Product Number EC300RF; c) MASTER CONSOLE EC300 LEGEND E
• Z-0158-2022 · Aug 31, 2021 · Open, Classified
  Medtronic Sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the Midas Rex Microsaw and Triton System with
• Z-2085-2016 · May 13, 2016 · Terminated
  Saw Sagittal Catalog Number: ES 300; Saw Sagittal Refurbished Catalog Number: ES300-R; Saw Saggital, Finger Catalog Number: ES310; Saw Saggital, Finger Refurbished Catalog Number: