N/A 1884070RTDRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00643169434646), received between Jan 29, 2019 and Sep 25, 2026 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Break” (8 reports).

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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Break

  It was reported that The burr was damaged upon removal from the sterile packaging and could not be used in the procedure, as it would not fit the M5 microdebrider. A new one had to be opened, which was in perfect condition (like all the others). There is no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50897741 ↗
• MalfunctionMay 21, 2025Vibration; Vibration

  IT WAS REPORTED THAT THE BUR BROKE DURING LOTHROPS FUNCTIONAL ENDOSCOPIC SINUS SURGERY PROCEDURE WHEN DRILLING IN THE FRONTAL SINUS. AFTER A FEW MINUTES OF DRILLING. THE BUR WAS WOBBLING. THE BUR WILL START TO ROTATE AROUND IN THE SHAFT SO IT IS NOT STABLE/FIXED POSITION ANYMORE. THE LOCK ON THE M5 WAS LOCKED DOWN. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22058189 ↗
• MalfunctionDec 30, 2024Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT BUR MADE WEIRD NOISE 45MIN INTO CASE AND STOPPED SPINNING. IT SEEMS THAT INNER PART OF DRILL STOPPED SPINNING/ BROKE. THE PROCEDURE WAS COMPLETED WITH THE REPORTED PRODUCTS. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21033069 ↗
• MalfunctionDec 2, 2024Break; Break

  ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE BUR WAS INTACT WHEN THE SURGEON BEGAN USING IT. HOWEVER, THE SURGEON NOTICED IT WASN¿T PERFORMING PROPERLY, AND THE INNER SECTION OF THE BUR CAME OUT. THE BUR STOPPED FUNCTIONING WHILE BEING USED AT 30K ON THE PATIENT. THE SURGEON HAD TO USE 3 SEPARATE BURS IN ORDER TO COMPLETE THE PROCEDURE. ALL 3 BURS FAILED TO OPERATE AS THEY SHOULD HAVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20818930 ↗
• MalfunctionDec 2, 2024Break; Break

  ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE BUR WAS INTACT WHEN THE SURGEON BEGAN USING IT. HOWEVER, THE SURGEON NOTICED IT WASN¿T PERFORMING PROPERLY, AND THE INNER SECTION OF THE BUR CAME OUT. THE BUR STOPPED FUNCTIONING WHILE BEING USED AT 30K ON THE PATIENT. THE SURGEON HAD TO USE 3 SEPARATE BURS IN ORDER TO COMPLETE THE PROCEDURE. ALL 3 BURS FAILED TO OPERATE AS THEY SHOULD HAVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20818858 ↗
• MalfunctionJun 18, 2024Break; Break

  IT WAS REPORTED THAT DURING SKULL BASE PROCEDURE WITH STEALTH NAVIGATION BUR BROKE AND STARTED SPINNING IN SHAFT OF M5. NO FRAGMENTS/PIECES DETACHED. PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19555490 ↗
• MalfunctionMay 20, 2024Break; Break

  IT WAS REPORTED THAT DURING DRAF 3 PROCEDURE SHORTLY AFTER STARTING, THE DRILL BROKE. PROCEDURE WAS COMPLETED WITH ANOTHER DRILL. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19349195 ↗
• MalfunctionJun 7, 2023Vibration; Vibration

  IT WAS REPORTED THAT DURING PROCEDURE BUR WAS VERY LOOSE AT THE BASE AND WAS MOVING WHILE DOCTOR WAS USING IT. SALES REPRESENTATIVE WAS PRESENT DURING THE CASE AND THEY DECIDED TO SWITCH THE BUR AND SECOND BUR WAS FINE AND FROM A DIFFERENT LOT. THERE WAS NO PATIENT IMPACT. NO SURGERY DELAY REPORTED. ADDITIONAL INFORMATION RECEIVED AND IT CLARIFIED THAT THE BUR WAS WOBBLING AND MOVING DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17083421 ↗
• MalfunctionFeb 27, 2019Break; Break

  A HEALTHCARE PROVIDER (HCP) REPORTED VIA MANUFACTURER REPRESENTATIVE THAT THE BUR QUICKLY BROKE DURING THE PROCEDURE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8374631 ↗
• MalfunctionFeb 14, 2019Overheating of Device; Contamination /Decontamination Problem; Overheating of Device; Contamination /Decontamination Problem

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE THREE BURS WERE SMOKING AND GIVING OFF BLACK RESIDUE IN THE NASAL CAVITY DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. THEY SWITCHED TO A SECOND HANDPIECE AND STILL HAD THE SAME ISSUE. IT WASN'T UNTIL THE FOURTH BUR THAT THE SMOKING HAD STOPPED. THE DEVICES WERE USED FOR A FRONTAL SINUS DRILL OUT/ THICK BONE DRILL OUT. THE IRRIGATION WAS ATTACHED AND WAS WORKING AT 30K RPM. THE HANDPIECES ALSO BECAME VERY WARM GRADUALLY, BOTH OF THE HANDPIECES WERE FUNCTIONING WITH BURS AT FIRST. IT WAS NOTED THAT THE CONSOLE WAS WORKING PROPERLY. THE HCP CONFIRMED THAT THE BURS WERE NOT RE-USED OR REPROCESSED. THERE WAS A PROCEDURE DELAY OF LESS THAN 1 HOUR. IT WAS ALSO NOTED THAT THEY WERE SUCCESSFUL WITH SOME BURS FROM THE DIFFERENT BATCH. THERE WAS NO PATIENT IMPACT OR INJURY. UPON FOLLOW-UP, IT WAS REPORTED THAT THERE WERE A TOTAL OF FIVE BURS THAT WERE SMOKING DURING THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8339355 ↗
• MalfunctionFeb 14, 2019Overheating of Device; Contamination /Decontamination Problem; Overheating of Device; Contamination /Decontamination Problem

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE THREE BURS WERE SMOKING AND GIVING OFF BLACK RESIDUE IN THE NASAL CAVITY DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. THEY SWITCHED TO A SECOND HANDPIECE AND STILL HAD THE SAME ISSUE. IT WASN'T UNTIL THE FOURTH BUR THAT THE SMOKING HAD STOPPED. THE DEVICES WERE USED FOR A FRONTAL SINUS DRILL OUT/ THICK BONE DRILL OUT. THE IRRIGATION WAS ATTACHED AND WAS WORKING AT 30K RPM. THE HANDPIECES ALSO BECAME VERY WARM GRADUALLY, BOTH OF THE HANDPIECES WERE FUNCTIONING WITH BURS AT FIRST. IT WAS NOTED THAT THE CONSOLE WAS WORKING PROPERLY. THE HCP CONFIRMED THAT THE BURS WERE NOT RE-USED OR REPROCESSED. THERE WAS A PROCEDURE DELAY OF LESS THAN 1 HOUR. IT WAS ALSO NOTED THAT THEY WERE SUCCESSFUL WITH SOME BURS FROM THE DIFFERENT BATCH. THERE WAS NO PATIENT IMPACT OR INJURY. UPON FOLLOW-UP, IT WAS REPORTED THAT THERE WERE A TOTAL OF FIVE BURS THAT WERE SMOKING DURING THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8339341 ↗
• MalfunctionFeb 14, 2019Overheating of Device; Contamination /Decontamination Problem; Overheating of Device; Contamination /Decontamination Problem

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE THREE BURS WERE SMOKING AND GIVING OFF BLACK RESIDUE IN THE NASAL CAVITY DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. THEY SWITCHED TO A SECOND HANDPIECE AND STILL HAD THE SAME ISSUE. IT WASN'T UNTIL THE FOURTH BUR THAT THE SMOKING HAD STOPPED. THE DEVICES WERE USED FOR A FRONTAL SINUS DRILL OUT/ THICK BONE DRILL OUT. THE IRRIGATION WAS ATTACHED AND WAS WORKING AT 30K RPM. THE HANDPIECES ALSO BECAME VERY WARM GRADUALLY, BOTH OF THE HANDPIECES WERE FUNCTIONING WITH BURS AT FIRST. IT WAS NOTED THAT THE CONSOLE WAS WORKING PROPERLY. THE HCP CONFIRMED THAT THE BURS WERE NOT RE-USED OR REPROCESSED. THERE WAS A PROCEDURE DELAY OF LESS THAN 1 HOUR. IT WAS ALSO NOTED THAT THEY WERE SUCCESSFUL WITH SOME BURS FROM THE DIFFERENT BATCH. THERE WAS NO PATIENT IMPACT OR INJURY. UPON FOLLOW-UP, IT WAS REPORTED THAT THERE WERE A TOTAL OF FIVE BURS THAT WERE SMOKING DURING THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8339302 ↗
• MalfunctionFeb 14, 2019Overheating of Device; Contamination /Decontamination Problem; Overheating of Device; Contamination /Decontamination Problem

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE THREE BURS WERE SMOKING AND GIVING OFF BLACK RESIDUE IN THE NASAL CAVITY DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. THEY SWITCHED TO A SECOND HANDPIECE AND STILL HAD THE SAME ISSUE. IT WASN'T UNTIL THE FOURTH BUR THAT THE SMOKING HAD STOPPED. THE DEVICES WERE USED FOR A FRONTAL SINUS DRILL OUT/ THICK BONE DRILL OUT. THE IRRIGATION WAS ATTACHED AND WAS WORKING AT 30K RPM. THE HANDPIECES ALSO BECAME VERY WARM GRADUALLY, BOTH OF THE HANDPIECES WERE FUNCTIONING WITH BURS AT FIRST. IT WAS NOTED THAT THE CONSOLE WAS WORKING PROPERLY. THE HCP CONFIRMED THAT THE BURS WERE NOT RE-USED OR REPROCESSED. THERE WAS A PROCEDURE DELAY OF LESS THAN 1 HOUR. IT WAS ALSO NOTED THAT THEY WERE SUCCESSFUL WITH SOME BURS FROM THE DIFFERENT BATCH. THERE WAS NO PATIENT IMPACT OR INJURY. UPON FOLLOW-UP, IT WAS REPORTED THAT THERE WERE A TOTAL OF FIVE BURS THAT WERE SMOKING DURING THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8339246 ↗
• MalfunctionFeb 14, 2019Overheating of Device; Contamination /Decontamination Problem; Overheating of Device; Contamination /Decontamination Problem

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE THREE BURS WERE SMOKING AND GIVING OFF BLACK RESIDUE IN THE NASAL CAVITY DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. THEY SWITCHED TO A SECOND HANDPIECE AND STILL HAD THE SAME ISSUE. IT WASN'T UNTIL THE FOURTH BUR THAT THE SMOKING HAD STOPPED. THE DEVICES WERE USED FOR A FRONTAL SINUS DRILL OUT/ THICK BONE DRILL OUT. THE IRRIGATION WAS ATTACHED AND WAS WORKING AT 30K RPM. THE HANDPIECES ALSO BECAME VERY WARM GRADUALLY, BOTH OF THE HANDPIECES WERE FUNCTIONING WITH BURS AT FIRST. IT WAS NOTED THAT THE CONSOLE WAS WORKING PROPERLY. THE HCP CONFIRMED THAT THE BURS WERE NOT RE-USED OR REPROCESSED. THERE WAS A PROCEDURE DELAY OF LESS THAN 1 HOUR. IT WAS ALSO NOTED THAT THEY WERE SUCCESSFUL WITH SOME BURS FROM THE DIFFERENT BATCH. THERE WAS NO PATIENT IMPACT OR INJURY. UPON FOLLOW-UP, IT WAS REPORTED THAT THERE WERE A TOTAL OF FIVE BURS THAT WERE SMOKING DURING THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8339151 ↗
• MalfunctionJan 29, 2019Break; Material Separation; Break; Material Separation

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE DEVICE WAS SEPARATED AND BROKE DURING A PROCEDURE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8286677 ↗