NA TN45RCDRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613994776266), received between Dec 19, 2017 and Jun 20, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 20, 2025Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT DURING PRE-OP THERE WAS NO NOTICEABLE DAMAGE NOTICED ON THE PRODUCT PACKAGE. THE BLADE WAS DAMAGE OR BREAKAGE UPON OPENING AND SLIPPED DURING SETTING (THE TOOL END TIP DID NOT ROTATE). USER MENTIONED BREAKAGE NOT BE OBSERVED VISUALLY, HOWEVER, THE SHAFT SHOULD BE BROKEN INSIDE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22295683 ↗
• MalfunctionFeb 20, 2020Material Fragmentation; Material Fragmentation

  ADDITIONAL INFORMATION RECEIVED FROM REP STATING THAT THERE WERE NO FRAGMENTS LEFT IN THE PATIENT. IT WAS REMOVED BY THE SURGEON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9732853 ↗
• MalfunctionDec 19, 2017Break; Material Fragmentation; Break; Material Fragmentation

  THE CUSTOMER REPORTED THE BUR BROKE DURING USE. THERE WAS NO INJURY REPORTED AS A RESULT OF THIS EVENT. NO FRAGMENTS OF THE BLADE WERE LEFT INSIDE THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7128482 ↗

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: