N/A 1885061HS (UDI 20681490693060)Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 20681490693060), received between Jan 3, 2017 and Jul 24, 2025 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Break” (17 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 24, 2025Break; Break

  IT WAS REPORTED THAT DURING ENDOSCOPIC PARANASAL SINUS SURGERY THE BUR WAS BROKEN, THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT(S). THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22587986 ↗
• MalfunctionNov 4, 2024Break; Break

  IT WAS REPORTED THAT DURING ENDOSCOPIC SINUS SURGERY, THREE BURS TIP WAS BROKEN. THERE WERE NO FRAGMENTS DETACHED FROM THE BURS. NUMBER OF ROTATIONS WAS 12000. ALL THE THREE BURS WERE USED WITH SAME M5 HANDPIECE. THERE WAS A PROCEDURAL DELAY OF TEN MINUTES AND THE SURGERY WAS COMPLETED USING ANOTHER BUR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20596183 ↗
• MalfunctionSep 2, 2024Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT INTRA-OP, THE BUR DID NOT ROTATE NORMALLY, IT WAS IN THE STATE OF ROTATING IDLE. UPON CHECKING THE BUR, THE ROOT PART WAS DETACHED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20116347 ↗
• MalfunctionApr 15, 2024Break; Break

  ADDITIONAL INFORMATION RECEIVED THAT THE BUR WAS BROKEN WHILE TRYING TO REMOVE FROM THE HANDPIECE. THERE WAS NO PATIENT IMPACT, WHICH DOES NOT MEET THE REPORTING CRITERIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19103896 ↗
• MalfunctionMar 5, 2024Break; Break

  ADDITIONAL INFORMATION RECEIVED: REP OBTAINED THE INFORMATION FROM THE CUSTOMER AS BUR ROOT WAS MELTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18834878 ↗
• MalfunctionJan 17, 2024Break; Break

  IT WAS REPORTED THAT PRE-OP, THE BUR WAS OPENED AND THE HANDPIECE WAS CONNECTED, AND IT WAS FOUND THAT IT WAS BROKEN. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18528355 ↗
• MalfunctionDec 19, 2023Break; Break

  IT WAS REPORTED THAT DURING THYROID-RELATED EYE DISEASE TREATING, THE GRINDING HEAD NECK OF THE DISPOSABLE DRILL BIT WAS BROKEN AND COULD NOT BE USED ANYMORE. SURGEON STOPPED USING IT AND REPLACED IT WITH A NEW DISPOSABLE DRILL BIT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18354522 ↗
• MalfunctionDec 14, 2023Break; Break

  IT WAS REPORTED THAT INTRA-OP, DURING AN INTERVENTION THE PART OF THE BUR THAT CLIPS ON BECOMES DISENGAGED FROM THE BUR WHICH IS USED ON THE MICRODEBRIDER HANDPIECE. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18326138 ↗
• MalfunctionDec 14, 2023Break; Break

  IT WAS REPORTED THAT INTRA-OP, DURING AN INTERVENTION THE PART OF THE BUR THAT CLIPS ON BECOMES DISENGAGED FROM THE BUR WHICH IS USED ON THE MICRODEBRIDER HANDPIECE. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18326017 ↗
• MalfunctionDec 12, 2023Break; Break

  IT WAS REPORTED THAT DURING USE, A DISPOSABLE BUR WAS USED TO TO GRIND BONES DURING SURGERY FOR TREATMENT OF THYROID-RELATED EYE DISEASES. THE NECK OF THE DISPOSABLE BUR BROKE AND COULD NOT BE USED ANYMORE. STOPPED USING IT IMMEDIATELY AND REPLACED IT WITH A NEW DISPOSABLE BUR. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18309062 ↗
• MalfunctionSep 2, 2023Break; Break

  IT WAS REPORTED THAT DURING THE OPERATION, IT WAS FOUND THAT THE DRILL BIT TIP END WAS STUCK IN THE DRILL BIT SLEEVE. AFTER REMOVING IT, IT WAS FOUND THAT THE INSIDE OF THE DRILL BIT MOVED, AND THE TAIL END PROLAPSED. THERE WAS 6 MIN DELAY IN THE PROCEDURE. THE BUR BROKE WHILE USING ON PATIENT AND THERE WAS NO FRAGMENT DETACHED FROM THE BUR. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17674947 ↗
• MalfunctionAug 18, 2023Vibration; Vibration

  IT WAS REPORTED THAT DURING INTRA-OP, THE TAIL OF THE DRILL CAME OUT, CAUSING THE POSITION OF THE TIP TO MOVE, MAKING IT IMPOSSIBLE TO USE NORMALLY. THE BUR WAS WOBBLING DURING USE. THERE WAS 10 MIN OF DELAY IN THE PROCEDURE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17570097 ↗
• MalfunctionSep 16, 2021Material Fragmentation; Material Fragmentation

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT WHEN THE BUR WAS TRIED TO BE USED DURING AN ENDOSCOPIC SINUS SURGERY (ESS), THE IRRIGATION NOZZLE WAS DAMAGED, SO IT WAS REPLACED WITH A BACKUP DEVICE. THERE WERE FRAGMENTS DETACHED FROM THE BUR, BUT THE FRAGMENTS DID NOT FALL INTO THE PATIENT. IT WAS NOTED THAT THE DEVICE WAS BEING USED AS USUAL. THERE WAS NO TROUBLESHOOTING DONE. THERE WAS NO DELAY IN THE PROCEDURE AS A RESULT OF THIS EVENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12482760 ↗
• MalfunctionAug 4, 2021Material Separation; Material Separation

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED VIA MANUFACTURER REPRESENTATIVE THAT DURING A PROCEDURE FOR PITUITARY SURGERY, THE CONNECTION AT THE BASE OF THE BUR BROKE OR CAME OFF DURING DRILLING. A BACKUP PRODUCT WAS USED, BUT THE SAME ISSUE OCCURRED. THERE WAS A 10-MINUTE DELAY IN THE SURGICAL PROCEDURE. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT(S). THE PATIENT WAS ALIVE. NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12274340 ↗
• MalfunctionAug 4, 2021Break; Break

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED VIA MANUFACTURER REPRESENTATIVE THAT THE TIP OF THE BUR BROKE BUT NOT DETACHED WHILE BEING USED ON A PATIENT AND STUCK IN THE HANDPIECE DURING THE FUNCTIONAL ENDOSCOPIC SINUS SURGERY PROCEDURE. THE BROKEN PARTS WERE CONTAINED IN THE OUTER BLADE. THERE WAS NO FRAGMENTS THAT CAME OFF OR GOT DETACHED FROM THE BROKEN DEVICE. THERE WERE NO FRAGMENTS THAT THAT GET IN CONTACT WITH THE PATIENT. THERE WAS NO BROKEN PIECES OF THE REPORTED PRODUCT REMAIN INSIDE THE PATIENT'S BODY. THERE WAS NO INTERVENTION PLANNED OR PERFORMED. THERE WAS NO BROKEN PIECES OF THE REPORTED PRODUCT REMAIN INSIDE THE PATIENT'S BODY. THERE WAS NO BACK-UP DEVICE USED. THE CASE WAS COMPLETED BY USING OTHER INSTRUMENTS INSTEAD OF THE BURR. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12273435 ↗
• MalfunctionDec 30, 2019Break; Mechanical Jam; Break; Mechanical Jam

  A HEALTH CARE PROVIDER REPORTED THAT THE DURING THE USE IN THE PROCEDURE, THE PRODUCT SUDDENLY STOPPED ROTATING. WHEN THE PRODUCT WAS REMOVED, THE BOTTOM OF THE BUR WAS BROKEN. ON FOLLOW UP, IT WAS STATED THAT THERE WERE FRAGMENTS DETACHED FROM THE DEVICE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9531965 ↗
• MalfunctionAug 10, 2018Break; Break

  A HEALTHCARE PROFESSIONAL REPORTED VIA A MANUFACTURING REPRESENTATIVE (REP) THAT TWO NEW BURS WERE BROKEN DURING AN OPERATION. IT WAS NOTED THAT THE DOCTOR DEALT WITH THE ISSUE IN TIME AND THERE WAS NO DAMAGE TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7774269 ↗
• MalfunctionAug 10, 2018Break; Break

  A HEALTHCARE PROFESSIONAL REPORTED VIA A MANUFACTURING REPRESENTATIVE (REP) THAT TWO NEW BURS WERE BROKEN DURING AN OPERATION. IT WAS NOTED THAT THE DOCTOR DEALT WITH THE ISSUE IN TIME AND THERE WAS NO DAMAGE TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7774251 ↗
• MalfunctionMay 17, 2017Break; Break

  THE SALES REP PROVIDED ADDITIONAL INFORMATION INDICATING THAT THE BUR BROKE AT THE TIP, BUT THE BREAK DID NOT RESULT IN FRAGMENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6572435 ↗
• MalfunctionJan 3, 2017Break; Break

  IT WAS REPORTED THAT THE BUR BROKE AT THE BASE WHILE IN USE. A REPLACEMENT BUR WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6219190 ↗