NA TN40RCDRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00613994776242), received between Dec 21, 2017 and Jun 14, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Break” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 14, 2026Material Fragmentation

  IT WAS REPORTED THAT INTRA-OP, THE BUR FRACTURED DURING THE PROCEDURE. THE SHAFT WAS BROKEN. THE FRAGMENTS PIECES DETACHED FROM THE BUR. THE PATIENTS WAS NOT ADVERSELY AFFECTED. THE FRACTURED PORTION WAS REMOVED AND DID NOT AFFECT THE PATIENT. ANOTHER NEW BUR WASUSED INSTEAD TO COMPLETE THE PROCEDURE. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25497705 ↗
• MalfunctionApr 1, 2025Break; Loose or Intermittent Connection; Use of Device Problem; Break; Loose or Intermittent Connection; Use of Device Problem

  IT WAS REPORTED THAT PRE-OP, THE SURGEON OPENED THE PACKAGE AND INSTALL TO THE MOTOR, THEN TESTING RUN AND HE FEEL THE DRILL BIT WAS NOT RUNNING, THEN HE TRIES TO TOUCH THE DIAMOND PART, AND NOTICED THE BURR PART WAS LOOSE AND CAN BE TAKEN OUT. THE PROCEDURE WAS DELAYED BY ONE MINUTE AND THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT(S). THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21742513 ↗
• MalfunctionJan 21, 2025Break; Break

  IT WAS REPORTED THAT TRANS NASAL BUR WAS NOT WORKING. WAS INSPECTED AND NOTED BY SURGEON AND SCRUB TEETH TO COME APART IN 2 PIECES. NO IMPACT OR CONSEQUENCE TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21195615 ↗
• MalfunctionAug 8, 2024Break; Break

  IT WAS REPORTED THAT PRIOR TO THE TRANS-NASAL SURGERY, THE BUR WAS BROKEN INSIDE ITSELF. THE INNER SHAFT THAT SUPPORTS THE BUR CAN BE DISCONNECTED FROM THE EXTERNAL TUBE WHEN PULLED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19936046 ↗
• MalfunctionDec 19, 2023Break; Break

  ADDITIONAL INFORMATION RECEIVED STATING THAT THE PHYSICAL DEVICE WAS DISCARDED BY THE CLIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18356710 ↗
• MalfunctionJan 5, 2023Break; Break

  IT WAS REPORTED BY HEALTH CARE PROFESSIONAL THAT DURING THE DOCTOR'S PREOPERATIVE PREPARATION PROCESS, THE PACKAGE WAS UNPACKED, IT WAS FOUND THAT THERE WERE CRACKS AT THE INTERFACE. IT WAS SUSPECTED THAT THERE WERE DAMAGES TO THE PRODUCTS CAUSED BY EXTRUSION DURING THE PROCESS OF LEAVING THE FACTORY OR TRANSPORTING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16101029 ↗
• MalfunctionNov 7, 2022Vibration; Vibration

  IT WAS REPORTED THAT TRANS NASAL BUR IS WOBBLING IN FIRST USE AND SURGEONS FOUND VERY CHALLENGING TO USE NEAR THE VITAL STRUCTURES. THERE IS NO PATIENT INVOLVED IN THIS EVENT. NO HARM HAPPENED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15742002 ↗
• MalfunctionNov 14, 2019Material Separation; Material Separation

  A HEALTH CARE PROVIDER (HCP) REPORTED THAT A THE DOCTOR REMOVED THE DRILL FROM HOLING SLEEVE ON THE SIDE OF THE BED AND THE BURR TIP FELL OUT DURING A TRANSSPHENOIDAL WITH NAVIGATION PROCEDURE. THE DEVICE DID NOT HAVE CONTACT WITH THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9320427 ↗
• MalfunctionApr 12, 2019Mechanical Problem; Material Separation; Mechanical Problem; Material Separation

  THE HEALTH CARE PROVIDER (HCP) REPORTED VIA MANUFACTURER REPRESENTATIVE THAT THE BUR'S TIP WAS SEPARATE AND LOOSE PRIOR TO THE PROCEDURE. THEY JUST OPENED THE PACKAGE AND NOTICED THAT THE BUR WAS LOOSE FROM THE OUTER PART AND CANNOT BE USED AT ALL. THIS WAS THE FIRST TIME THE BUR WAS USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8508571 ↗
• MalfunctionJun 26, 2018Break; Break

  THE SURGEON REPORTED THAT THE TIP OF THE BUR BROKE DURING THE PROCEDURE; THE INITIAL INFORMATION INDICATED THAT THE SURGEON HURT HIS HAND AS A RESULT, BUT THE FOLLOW-UP STATED THAT THERE WAS NO MEDICAL ATTENTION OR INTERVENTION NECESSARY AFTER THE FACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7638729 ↗
• MalfunctionDec 21, 2017Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT DURING SURGERY, THE BUR BROKE AT THE CUTTING EDGE AND BECAME DETACHED. THE FRAGMENT WAS SUCCESSFULLY REMOVED WITH NO INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7139924 ↗

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: