NA TN30MFLRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00613994776211), received between Jul 7, 2017 and Nov 12, 2018 — classified as 4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 12, 2018Mechanical Jam; Mechanical Jam

  A HEALTH CARE PROFESSIONAL (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE BUR ON THE HANDPIECE WOULD NOT TURN WHEN THE FOOTSWITCH WAS PRESSED. ANOTHER BUR WAS USED ON THE HANDPIECE AND WORKED FINE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8059480 ↗
• MalfunctionMay 1, 2018Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT THE TIP OF THE DRILL BIT SPUN AROUND AND FELL OUT OF THE SHEATH WHEN THE SURGEON TESTED IT BEFORE USE. THE PRODUCT WAS UNUSABLE AND THERE WAS NO PATIENT HARM BECAUSE THE PRODUCT NEVER HAD PATIENT CONTACT. ON FOLLOW UP, IT WAS REPORTED THAT THE EVENT OCCURRED ON (B)(6) 2017 AND A NEW BUR WAS OPENED TO COMPLETE THE CASE. IT WAS THE INITIAL USE OF THE BUR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7475261 ↗
• MalfunctionMay 1, 2018Break; Material Separation; Break; Material Separation

  A CUSTOMER REPORTED THAT THE SURGEON ATTEMPTED TO USE THE BUR BUT THE HEAD OF THE DRILL WOULD NOT SPIN. THE TOP OF THE BUR HEAD HAD DISCONNECTED FROM THE BASE AND WAS BROKEN. THE BUR WAS NOT USED ON THE PATIENT SO THERE WAS NO PATIENT HARM.

  Patient problems: No Patient Involvement

  MAUDE report 7475160 ↗
• MalfunctionJul 7, 2017Break; Break

  THE FACILITY REPORTED THAT THE END OF THE DEVICE CAME OFF FROM THE HANDLE DURING THE PROCEDURE. IT WAS DIFFICULT TO FIND, THE PART OF THE DEVICE THAT CAME OFF. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6695389 ↗

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 EH
• 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: