N/A 1882969 (UDI 20763000040950)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 20763000040950), received between Nov 25, 2022 and Jun 28, 2024 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 28, 2024Break; Break

  IT WAS REPORTED THAT PRIOR TO USE, THE TIP OF THE BUR WAS BROKEN OFF WHEN USED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19633439 ↗
• MalfunctionJun 28, 2024Break; Break

  IT WAS REPORTED THAT PRIOR TO USE, THE TIP OF THE BUR WAS BROKEN OFF WHEN USED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19633369 ↗
• MalfunctionNov 9, 2023Break; Break

  ADDITIONAL INFORMATION RECEIVED AND INDICATED THAT THE BUR BROKEN WHILE BEING USED ON A PATIENT. THERE WAS NO ANY FRAGMENTS/PIECES DETACH FROM THE BROKEN DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18104455 ↗
• MalfunctionMay 9, 2023Break; Break

  IT WAS REPORTED BY HEALTH CARE PROFESSIONAL THAT DURING USE AFTER INSTALLING BUR IN THE HANDPIECE, INNER SHAFT OF BUR BROKE AND DETACHED WHEN ROTATING. THERE WERE NO FRAGMENTS DETACHED. REPLACED IT WITH THE SAME MODEL AND THE SAME LOT AND IT WAS BROKEN AGAIN. REPLACED WITH ANOTHER BLADE TO COMPLETE THE SURGERY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16899786 ↗
• MalfunctionMay 9, 2023Break; Break

  IT WAS REPORTED BY HEALTH CARE PROFESSIONAL THAT DURING USE AFTER INSTALLING BUR IN THE HANDPIECE, INNER SHAFT OF BUR BROKE AND DETACHED WHEN ROTATING. THERE WERE NO FRAGMENTS DETACHED. REPLACED IT WITH THE SAME MODEL AND THE SAME LOT AND IT WAS BROKEN AGAIN. REPLACED WITH ANOTHER BLADE TO COMPLETE THE SURGERY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16899778 ↗
• MalfunctionMar 29, 2023Break; Break

  IT WAS REPORTED BY HEALTH CARE PROFESSIONAL THAT DURING PROCEDURE DIAMOND BUR WAS BROKEN AFTER LESS THEN 10 MINUTES OF USAGE. THERE WAS NO REPORTED PATIENT IMPACT. ADDITIONAL INFORMATION RECEIVED AFTER FOLLOW UP THAT THE TIP OF THE BUR WAS BROKEN, THE BALL TIP CAME OUT AFTER A FEW SECOND OF USE, THERE WAS NO FRAGMENTS/PIECES CAME IN CONTACT WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16640019 ↗
• MalfunctionMar 29, 2023Break; Break

  IT WAS REPORTED BY HEALTH CARE PROFESSIONAL THAT DURING PROCEDURE DIAMOND BUR WAS BROKEN AFTER LESS THEN 10 MINUTES OF USAGE. THERE WAS NO REPORTED PATIENT IMPACT. ADDITIONAL INFORMATION RECEIVED AFTER FOLLOW UP THAT THE TIP OF THE BUR WAS BROKEN, THE BALL TIP CAME OUT AFTER A FEW SECOND OF USE, THERE WAS NO FRAGMENTS/PIECES CAME IN CONTACT WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16639972 ↗
• MalfunctionMar 2, 2023Break; Break

  IT WAS REPORTED BY HEALTH CARE PROFESSIONAL THAT THE IT WAS A CONSUMABLE BUR THAT FITS INTO A CAPITAL HANDPIECE. THE HEALTH CARE PROFESSIONAL WAS DRILLING FOR ABOUT 5 MIN, THEN THE BUR STOPPED ROTATING AND WHEN TAKEN OUT THE HEALTH CARE PROFESSIONAL SAW THE FRONT TIP WAS BROKEN OFF AND LOOSE FROM THE SHAFT. NO FRAGMENT FELL INTO PATIENT, NO HAR, WAS DONE DURING THE DCR PROCEDURE. NO INTERVENTION PLANNED OR PERFORMED. HEALTH CARE PROFESSIONAL WAS ABLE COMPLETE THESE PROCEDURES WITHOUT A HANDPIECE MICRODEBRIDER, BY USING INSTRUMENTS. THERE WAS 30 MINUTES DELAY IN THE PROCEDURE THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16475828 ↗
• MalfunctionJan 10, 2023Break; Break

  IT IS REPORTED BY HCP THAT WHEN THE BUR WAS INSTALLED, ENTERED THE NASAL CAVITY, AND THE BUR WAS BROKEN WHEN THE PEDAL WAS STEPPED ON DURING PROCEDURE. THERE WAS NO KNOWN PATIENT IMPACT. ON FOLLOW-UP, IT WAS REPORTED THAT AFTER ENTERING THE NASAL CAVITY, THE BUR BROKE. THERE WAS CONTACT WITH THE BONE AND 2 PIECES OF THE SAME MODEL (1882969) WERE CONTINUOUSLY BROKEN. INNER SHAFT WAS FRACTURED. BROKEN PIECE WAS TAKEN OUT WITH PLIERS IN THE NASAL CAVITY. NO EFFECT ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16129185 ↗
• MalfunctionJan 10, 2023Break; Break

  IT IS REPORTED BY HCP THAT WHEN THE BUR WAS INSTALLED, ENTERED THE NASAL CAVITY, AND THE BUR WAS BROKEN WHEN THE PEDAL WAS STEPPED ON DURING PROCEDURE. THERE WAS NO KNOWN PATIENT IMPACT. ON FOLLOW-UP, IT WAS REPORTED THAT AFTER ENTERING THE NASAL CAVITY, THE BUR BROKE. THERE WAS CONTACT WITH THE BONE AND 2 PIECES OF THE SAME MODEL (1882969) WERE CONTINUOUSLY BROKEN. INNER SHAFT WAS FRACTURED. BROKEN PIECE WAS TAKEN OUT WITH PLIERS IN THE NASAL CAVITY. NO EFFECT ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16129155 ↗
• MalfunctionNov 25, 2022Break; Break

  IT WAS REPORTED THAT, DURING THE SURGERY THE BURS WERE BROKEN ONE AFTER ANOTHER, AND THE SURGERY COULD NOT BE COMPLETED NORMALLY. AFTER THEY WERE REPLACED, THEY WERE STILL INEFFECTIVE. IN THE SAME SURGERY, ALL THE 4 BURS WERE BROKEN. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15864427 ↗