N/A 1882969 (UDI 20681490613273)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 20681490613273), received between Jun 14, 2017 and Jan 31, 2025 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 31, 2025Vibration; Vibration

  IT WAS REPORTED THAT WHEN THE DRILL BIT WAS USED FOR THE FIRST TIME, THE LEFT AND RIGHT AMPLITUDE OF SWING WERE TOO LARGE AND IT COULDN'T BE USED NORMALLY. THE SWING WAS TOO LARGE, CAUSING THE BUR TO SHAKE WHEN IN USE. THE ISSUE WAS FOUND OUT WHEN THE USER WAS JUST USING IT DURING A FRONTAL SINUS SURGERY ( DURING INSTALLATION STAGE ) AND WAS NOT USED ON PATIENT. THERE WAS A SURGICAL DELAY OF 3 MINUTES. THERE WAS NO PATIENT IMPACT. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21281910 ↗
• MalfunctionMay 6, 2024Vibration; Dull, Blunt; Vibration; Dull, Blunt

  IT WAS REPORTED THAT DURING THE OPERATION, THE BUR HAD POOR POLISHING EFFECT WHICH COULD NOT BE POLISHED AND WAS NOT CUTTING THE TISSUE. THE BUR GRINDING FAILED. AFTER REPLACING WITH THE NEW BUR, THE OPERATION COULD BE NORMAL. THERE PROCEDURE WAS COMPLETED BY BACKUP PRODUCT AND THERE WAS A DELAY OF 5 MINUTES. THERE WAS NO PATIENT INJURY. ANALYSIS OF THE DEVICE CONFIRMED THAT THE BUR HAD EXCESSIVE WOBBLING WHEN OPERATED AT 6000 RPM IN FORWARD MODE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19245996 ↗
• MalfunctionMar 22, 2024Break; Break

  IT WAS REPORTED THAT BUR BROKEN DURING OPTIC NERVE DECOMPRESSION SURGERY. THE PROCEDURE WAS DELAYED UP TO 15 MINUTES. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. THERE WAS NO INJURY. ADDITIONAL INFORMATION RECEIVED THAT THE BUR TIP WAS BROKEN WHILE BEING USED ON A PATIENT. THE FRAGMENTS INSIDE THE PATIENT'S BODY WERE REMOVED WITH OPERATING ROOM FORCEPS WITHOUT LEAVING ANY RESIDUE. IT WAS THE CONSUMABLE THAT WAS DAMAGED, NOT THE DEVICE, SO THERE WERE NO PIECES FALLING OFF THE DAMAGED DEVICE. BECAUSE THIS CONSUMABLE WAS USED TO CONNECT THE DEVICE, THERE WAS NO PROBLEM WITH THE DEVICE. THE CONSUMABLE BROKE AND FELL OFF AND HAD BEEN COMPLETELY REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18956820 ↗
• MalfunctionFeb 23, 2024Break; Break

  IT WAS REPORTED DURING INTRA-OPERATIVE THAT THE FIRST BUR BROKE AFTER 5 SEC IN THE M5 THEY USE ANOTHER BUR, SAME SERIAL NUMBER, BUR BROKE VERY QUICKLY. THEY WERE UNABLE TO TAKE OFF THE BUR FROM THE M5. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18765111 ↗
• MalfunctionFeb 23, 2024Break; Break

  IT WAS REPORTED DURING INTRA-OPERATIVE THAT THE FIRST BUR BROKE AFTER 5 SEC IN THE M5 THEY USE ANOTHER BUR, SAME SERIAL NUMBER, BUR BROKE VERY QUICKLY. THEY WERE UNABLE TO TAKE OFF THE BUR FROM THE M5. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18765064 ↗
• MalfunctionApr 16, 2019Break; Break

  THE HEALTHCARE PROVIDER (HCP) REPORTED THAT THE BUR BROKE WITHIN 30 SECONDS AND JUST SPUN IN THE HANDPIECE. THE SECOND BUR BROKE TOWARDS THE END OF THE CASE AND ACTUALLY CAME OFF IN THE PATIENT AND WAS RETRIEVED WITH A FORCEP. THERE WAS NO INJURY TO THE PATIENT BUT IT JUST STOPPED SPINNING AND THE SHAFT WAS FRAGMENTED. THIS IS NOT THE FIRST TIME THE BURS HAVE SNAPPED BUT IT WAS THE FIRST TIME ONE BROKE OFF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8517956 ↗
• MalfunctionApr 16, 2019Material Separation; Mechanical Jam; Material Separation; Mechanical Jam

  THE HEALTH CARE PROVIDER REPORTED THAT THE BUR BROKE WITHIN 30 SECONDS AND JUST SPUN IN THE HANDPIECE. THE SECOND BUR BROKE TOWARDS THE END OF THE CASE AND ACTUALLY CAME OFF IN THE PATIENT AND WAS RETRIEVED WITH A FORCEP. THERE WAS NO INJURY TO THE PATIENT BUT IT JUST STOPPED SPINNING AND THE SHAFT WAS FRAGMENTED. THIS IS NOT THE FIRST TIME THE BURS HAVE SNAPPED BUT IT WAS THE FIRST TIME ONE BROKE OFF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8517947 ↗
• InjuryJun 14, 2017Material Fragmentation; Material Fragmentation

  THE SURGEON REPORTED THAT DURING A DCR "THE BUR BROKE INSIDE CAVITY NASAL OF THE PATIENT. THE BUR WAS BEING USED AT <6000RPM." "THE DRILL FRAGMENT WAS RECOVERED AFTER RADIOGRAPHY, WE HAD TO RETRACT THE PALATE WITH ASPIRATION PROBE AND REMOVED THE FRAGMENT THAT WAS HOUSED IN THE CAVUM"; THE FRAGMENT WAS REMOVED ORALLY AFTER X-RAY CONFIRMATION OF LOCATION. THERE WAS NO PATIENT INJURY.

  Patient problems: Radiation Exposure, Unintended

  MAUDE report 6642068 ↗