NA TN30RCDRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00613994776228), received between Dec 28, 2018 and Sep 17, 2025 — classified as 6 malfunctions.

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

• MalfunctionSep 17, 2025Break; Break

  IT WAS REPORTED THAT DURING PRE-OP, THE BUR MIDDLE BAR WAS PROTRUDING WHILE REMOVING FROM THE PACKAGE. IT WAS NOT BROKEN WHILE INSERTING AND REMOVING FROM HANDPIECE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23070040 ↗
• MalfunctionMar 17, 2025Break; Break

  IT WAS REPORTED THAT DURING TRANSPHENOIDAL SURGERY, DIAMOND BUR STOPS TURNING AND MILLING. WHEN REMOVING AND INSPECTING THE BUR AND THE AMOUNT, IT IS NOTED THAT THE BUR IS DETACHED FROM THE BASE. IT IS TESTED AGAIN BY INSERTING IT AND IT DOES NOT WORK. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. THERE IS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21616318 ↗
• MalfunctionDec 4, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT INTRA OP THE BLADE WAS JUST STARTED TO BE USED, THE GRINDING TIP HEAD BROKE AND THE PIECES FELL OFF. FRAGMENTS DID NOT COME IN CONTACT WITH PATIENT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15912612 ↗
• MalfunctionJul 20, 2022Material Separation; Material Separation

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT PRIOR TO USE, WHEN THE DRILL WAS BEING ASSEMBLED ON THE BACK TABLE, THIS SPECIFIC TRANS-NASAL BUR CAME APART. THE ACTUALLY DIAMOND BUR (DISTAL TIP) CAME OUT OF THE SHAFT OF IRRIGATION SLEEVE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15067590 ↗
• MalfunctionMay 18, 2022Break; Break

  THE HCP REPORTED THAT THE DRILL (BALL) SEPARATED (REMOVES COMPLETELY) FROM THE REST OF THE STEM BEFORE OPERATION. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14430992 ↗
• MalfunctionDec 28, 2018Material Fragmentation; Material Fragmentation

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT DURING A PITUITARY TUMOR PROCEDURE, THE SURGEON REMOVED THE DRILL BIT FROM THE PATIENT AND NOTICED THAT THE TIP HAD SHEARED OFF. ALL PIECES WERE REMOVED FROM THE PATIENT AND THEY PROCEEDED WITH THE CASE USING A DIFFERENT DRILL BIT. THERE WAS NO DELAY IN THE PROCEDURE. THERE WAS NO PATIENT IMPACT OR INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8202543 ↗

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: