N/A 1883672HS (UDI 20721902100561)Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 20721902100561), received between Dec 21, 2016 and Aug 11, 2026 — classified as 2 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Break” (21 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 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50205899 ↗
• MalfunctionJul 15, 2024Break; Break

  IT WAS REPORTED THAT DURING FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) , THE TIP OF THE BUR WAS BROKEN INTO 2 PIECES WHEN THE DOCTOR USED THE BUR FOR ABOUT 40 MINUTES. SO, THE DOCTOR CHANGED A NEW BUR TO COMPLETE THE SURGERY. THERE WAS NO DAMAGE TO TIP WHEN CHECKED PRIOR TO USE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19738048 ↗
• MalfunctionApr 12, 2024Break; Break

  IT WAS REPORTED THAT BUR TIP WAS BROKEN OFF AND STICKED IN THE FRONTAL SINUS.THERE WERE NO FRAGMENT PIECES REMAINING IN THE PATIENT. THE TIP COULD BE REMOVED WITH AN MANUAL INSTRUMENT. THERE WAS NO UNANTICIPATED MEDICAL INTERVENTIONS WERE PERFORMED TO REMOVE THE TIP OF THE BUR. PROCEDURE WAS COMPLETED WITH BACK UP PRODUCTS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19094941 ↗
• MalfunctionApr 5, 2024Break; Break

  IT WAS REPORTED THAT DURING USE AND DURING THE INTERVENTION AT THE TIME OF MILLING THE BONE, THE CUTTER SEPARATED FROM THE HANDPIECE OF THE MAGNUM. THE BUR WAS RETRIEVED FROM THE NASAL CAVITY USING FORCEPS. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19048197 ↗
• MalfunctionFeb 17, 2024Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT DURING PROCEDURE BUR WAS STUCK INSIDE THE M5 HANDPIECE. THERE WAS NO PATIENT IMPACT. IT WAS FOUND BUR SHAFT BROKE AND HUB DEFORMED DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18728180 ↗
• MalfunctionJul 18, 2023Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE IT WAS NECESSARY TO USE THIS DEVICE TO REMOVE THE FRONTAL OSTEOMA, WHILE USING THE DRILL IT BROKE. PROCEDURE DELAYED BY 20 MINUTES. ANOTHER DEVICE WAS OPENED TO COMPLETE THE PROCEDURE. PATIENT REPORTED TO BE ALIVE WITH NO INJURY. ON FOLLOW UP IT WAS REPORTED THAT NO FRAGMENTS DETACHED FROM THE BROKEN DEVICE. THE SPIRAL WRAP FROM THE INNER SHAFT WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17340223 ↗
• MalfunctionFeb 6, 2023Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING INTRA-OPERATIVE STAGE, A BUR WAS FOUND BROKEN OFF IN THE COLLET OF M5 HANDPIECE. A PIECE WAS STILL STUCK. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16309624 ↗
• MalfunctionJun 5, 2022Break; Break

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE DEVICE WAS USED AS NORMAL FOR BONE EXCISION, BUT THE TIP OF THE BUR WAS BROKEN AND BECAME UNUSABLE. THE EVENT OCCURRED DURING AN ESS PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE USE OF BACKUP PRODUCTS. THERE WAS NO DELAY AND NO PATIENT IMPACT. THERE WAS NOT ANY REMAINING DAMAGED PIECE IN THE PATIENT'S BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14599435 ↗
• MalfunctionJun 21, 2021Break; Break

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED VIA MANUFACTURER REPRESENTATIVE THAT THE BLADE BROKE DURING THE OPERATION. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12032589 ↗
• MalfunctionJun 1, 2021Material Separation; Material Separation

  IT WAS REPORTED BY A HEALTH CARE PROFESSIONAL THAT DURING A FRONTAL DRILL OUT THE BURS BROKE INTRA-OP THE DOCTOR ENDED UP OPENING 5 AND THE 5TH ONE WORKED FINE. ON FOLLOW UP IT WAS REPORTED THAT THE BUR BROKE WHILE BEING USED BY THE SURGEON. THE REAR END WAS THE PART OF THE BLADE THAT BROKE. THERE WAS NO MENTION ABOUT ANY FRAGMENTS FROM THE BROKEN DEVICE. THE PIECE THAT BROKE CAME OFF IN ONE PIECE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11913013 ↗
• MalfunctionJun 1, 2021Material Separation; Material Separation

  IT WAS REPORTED BY A HEALTH CARE PROFESSIONAL THAT DURING A FRONTAL DRILL OUT THE BURS BROKE INTRA-OP THE DOCTOR ENDED UP OPENING 5 AND THE 5TH ONE WORKED FINE. ON FOLLOW UP IT WAS REPORTED THAT THE BUR BROKE WHILE BEING USED BY THE SURGEON. THE REAR END WAS THE PART OF THE BLADE THAT BROKE. THERE WAS NO MENTION ABOUT ANY FRAGMENTS FROM THE BROKEN DEVICE. THE PIECE THAT BROKE CAME OFF IN ONE PIECE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11912958 ↗
• MalfunctionJun 1, 2021Material Separation; Material Separation

  IT WAS REPORTED BY A HEALTH CARE PROFESSIONAL THAT DURING A FRONTAL DRILL OUT THE BURS BROKE INTRA-OP THE DOCTOR ENDED UP OPENING 5 AND THE 5TH ONE WORKED FINE. ON FOLLOW UP IT WAS REPORTED THAT THE BUR BROKE WHILE BEING USED BY THE SURGEON. THE REAR END WAS THE PART OF THE BLADE THAT BROKE. THERE WAS NO MENTION ABOUT ANY FRAGMENTS FROM THE BROKEN DEVICE. THE PIECE THAT BROKE CAME OFF IN ONE PIECE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11912955 ↗
• MalfunctionJun 1, 2021Material Separation; Material Separation

  IT WAS REPORTED BY A HEALTH CARE PROFESSIONAL THAT DURING A FRONTAL DRILL OUT THE BURS BROKE INTRA-OP THE DOCTOR ENDED UP OPENING 5 AND THE 5TH ONE WORKED FINE. ON FOLLOW UP IT WAS REPORTED THAT THE BUR BROKE WHILE BEING USED BY THE SURGEON. THE REAR END WAS THE PART OF THE BLADE THAT BROKE. THERE WAS NO MENTION ABOUT ANY FRAGMENTS FROM THE BROKEN DEVICE. THE PIECE THAT BROKE CAME OFF IN ONE PIECE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11912856 ↗
• MalfunctionNov 18, 2020Material Fragmentation; Material Fragmentation

  A HEALTH CARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REPORTED THAT TIP OF THE BUR BROKE OFF IN THE PATIENT'S NOSE DURING THE PROCEDURE. THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT'S NOSE. THE SECOND BUR OPENED ALSO BROKE OFF AND WAS RETRIEVED. INTERVENTION WAS PERFORMED TO RETRIEVE THE BROKEN PIECES. THE PROCEDURE WAS DELAYED FOR 5 MINUTES. THE PROCEDURE WAS COMPLETED. THE PATIENT WAS UNHARMED. NO BROKEN PIECES OF THE REPORTED PRODUCT REMAIN INSIDE THE PATIENT'S BODY. ON FOLLOW UP, IT WAS STATED THAT THERE WERE NO ADDITIONAL PROCEDURES OR UNINTENDED EQUIPMENT REQUIRED TO RETRIEVE THE FRAGMENT, INSTRUMENTS ALREADY BEING USED IN THE PROCEDURE WERE USED AND NO ADDITIONAL PROCEDURES WERE NECESSARY. THE EVENT OCCURRED DURING FUNCTIONAL ENDOSCOPIC SINUS SURGERY IN THE FRONT SINUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10860272 ↗
• MalfunctionNov 18, 2020Material Fragmentation; Material Fragmentation

  A HEALTH CARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REPORTED THAT TIP OF THE BUR BROKE OFF IN THE PATIENT'S NOSE DURING THE PROCEDURE. THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT'S NOSE. THE SECOND BUR OPENED ALSO BROKE OFF AND WAS RETRIEVED. INTERVENTION WAS PERFORMED TO RETRIEVE THE BROKEN PIECES. THE PROCEDURE WAS DELAYED FOR 5 MINUTES. THE PROCEDURE WAS COMPLETED. THE PATIENT WAS UNHARMED. NO BROKEN PIECES OF THE REPORTED PRODUCT REMAIN INSIDE THE PATIENT'S BODY. ON FOLLOW UP, IT WAS STATED THAT THERE WERE NO ADDITIONAL PROCEDURES OR UNINTENDED EQUIPMENT REQUIRED TO RETRIEVE THE FRAGMENT, INSTRUMENTS ALREADY BEING USED IN THE PROCEDURE WERE USED AND NO ADDITIONAL PROCEDURES WERE NECESSARY. THE EVENT OCCURRED DURING FUNCTIONAL ENDOSCOPIC SINUS SURGERY IN THE FRONT SINUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10860239 ↗
• InjuryJul 14, 2020Material Fragmentation; Mechanical Jam; Material Fragmentation; Mechanical Jam

  ADDITIONAL INFORMATION RECEIVED FORM REP STATING THAT DURING FRONTAL SINUS SURGERY, THE FRAGMENT/TIP FELL WHEN IT DETACHED TO THE FRONTAL SINUS OF THE PATIENT. FRONTAL GIRAFFE WAS THE WAS INSTRUMENT USED TO RETRIEVE THE FRAGMENT. THE SPEED OF THE BUR BEING RUN WAS 12000 ON FORWARD. THERE WAS PROCEDURAL DELAY, NO BACK UP DEVICE WAS USED. THERE WAS NO ADDITIONAL PROCEDURES OR UNINTENDED EQUIPMENT REQUIRED TO LOCATE AND/OR RETRIEVE THE FRAGMENT. INSTRUMENTS AND RAD 60 BLADE WAS USED WHEN THE SECOND BUR WOULD NOT SPIN. THE PROCEDURE COMPLETED SUCCESSFULLY. THE PATIENT IS CURRENTLY DOING WELL. THERE WAS NO PATIENT IMPACT.

  Patient problems: Device Embedded In Tissue or Plaque; No Consequences Or Impact To Patient

  MAUDE report 10269188 ↗
• InjuryJul 14, 2020Material Fragmentation; Mechanical Jam; Material Fragmentation; Mechanical Jam

  ADDITIONAL INFORMATION RECEIVED FORM REP STATING THAT DURING FRONTAL SINUS SURGERY, THE FRAGMENT/TIP FELL WHEN IT DETACHED TO THE FRONTAL SINUS OF THE PATIENT. FRONTAL GIRAFFE WAS THE WAS INSTRUMENT USED TO RETRIEVE THE FRAGMENT. THE SPEED OF THE BUR BEING RUN WAS 12000 ON FORWARD. THERE WAS PROCEDURAL DELAY, NO BACK UP DEVICE WAS USED. THERE WAS NO ADDITIONAL PROCEDURES OR UNINTENDED EQUIPMENT REQUIRED TO LOCATE AND/OR RETRIEVE THE FRAGMENT. INSTRUMENTS AND RAD 60 BLADE WAS USED WHEN THE SECOND BUR WOULD NOT SPIN. THE PROCEDURE COMPLETED SUCCESSFULLY. THE PATIENT IS CURRENTLY DOING WELL. THERE WAS NO PATIENT IMPACT.

  Patient problems: Device Embedded In Tissue or Plaque; No Consequences Or Impact To Patient

  MAUDE report 10269183 ↗
• MalfunctionJan 28, 2020Break; Break

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED VIA MANUFACTURER REPRESENTATIVE THAT DURING A PROCEDURE FOR CHRONIC SINUSITIS, THE SURGEON REPORTED THAT 2 DIFFERENT BURS BROKE WHILE DRILLING OUT THE FRONTAL SINUS AT 12,000 RPM SPEED. AFTER THE SECOND BUR BROKE, A NEW BUR WAS BORROWED FROM ANOTHER FACILITY IN THE AREA; THERE WAS A 70 MINUTE DELAY. IT WAS CONFIRMED THAT NO FRAGMENTS OF THE BROKEN BURS REMAINED IN THE PATIENT; THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING BACK-UP PRODUCTS. THERE WAS NO PATIENT IMPACT/INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9636378 ↗
• MalfunctionAug 21, 2019Material Separation; Material Separation

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED VIA MANUFACTURER REPRESENTATIVE THAT THE BUR SNAPPED HALFWAY DURING DRILLING FOR A BILATERAL ENDOSCOPIC REMOVAL OF LARGE OSTEOMA BOTH FRONTAL SINUSES BILATERAL FESS, SEPTOPLASTY PROCEDURE. THE BUR BROKE OFF AND DETACHED. THERE WERE NO FRAGMENTS DETACHED FROM THE DEVICE. THE HANDPIECE WAS USED AND IPC SETTING AT MAX 12000RPM WITH 40CC/MIN IRRIGATION. THERE WAS NO INTERVENTION PLANNED OR PERFORMED. THERE WAS A 10 MINUTES DELAY WITH THE PROCEDURE. THERE WAS NO BROKEN PIECES REMAIN INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT(S). THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8914730 ↗
• MalfunctionAug 21, 2019Break; Break

  A HEALTHCARE PROVIDER (HCP) REPORTED THAT THE BUR BROKE FROM THE BEGINNING OF ITS USE. PATIENT IS ALIVE-NO INJURY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8914569 ↗
• MalfunctionDec 13, 2018Break; Break

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE BUR BROKE DURING A SURGERY ON THE NASOPHARYNGEAL FIBROMA. THE SURGEON DRILLED FOR 5 TO 10 MINUTES AT THE BACK WALL OF MAXILLARY SINUS. THERE WAS A 10 TO 15 MINUTES PROCEDURE DELAY BECAUSE THE SURGEON CHANGED THE BUR WITH A NEW ONE. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THE HCP NOTED THAT THIS WAS THE INITIAL USE OF THE DEVICE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8160983 ↗
• MalfunctionJun 7, 2018Material Fragmentation; Material Fragmentation

  DURING A SINUS PROCEDURE, THE TIPS OF TWO BURS BROKE OFF IN THE PATIENT. THERE WAS NO INJURY OR IMPACT AS A RESULT. THIS REPORT REPRESENTS ITEM DEVICE 1 OF 2.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7579664 ↗
• MalfunctionApr 16, 2018Break; Break

  THE CUSTOMER REPORTED THE SURGEON WAS USING THE BURS DURING A FESS PROCEDURE, AND TWO BURS FROM THE SAME LOT NUMBER BROKE AT THE SPIRAL WRAP. ALL PIECES WERE RETRIEVED FROM THE PATIENT AND NO HARM WAS DONE TO THE PATIENT. THE SURGEON USED ANOTHER BUR TO FINISH THE PROCEDURE. THIS REGULATORY REPORT IS FOR BUR 2 OF 2.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7432488 ↗
• MalfunctionApr 16, 2018Break; Break

  THE CUSTOMER REPORTED THE SURGEON WAS USING THE BURS DURING A FESS PROCEDURE, AND TWO BURS FROM THE SAME LOT NUMBER BROKE AT THE SPIRAL WRAP. ALL PIECES WERE RETRIEVED FROM THE PATIENT AND NO HARM WAS DONE TO THE PATIENT. THE SURGEON USED ANOTHER BUR TO FINISH THE PROCEDURE. THIS REGULATORY REPORT IS FOR BUR 1 OF 2.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7432473 ↗
• MalfunctionMar 8, 2018Break; Break

  THE CUSTOMER REPORTED THAT THE FIRST BUR TWISTED INSIDE THE PATIENT AND EVENTUALLY BROKE AT THE DISTAL END. A SECOND NEW BUR WAS OPENED AND USED WHERE THE SAME PROBLEM OCCURED, SO THEY HAD TO USE A THIRD ONE TO COMPLETE THE OPERATION. THERE WAS NO INJURY OR IMPACT ASSOCIATED WITH THE EVENT, BUT THE PROCEDURE WAS EXTENDED DUE TO THE CHANGING OF BURS. THIS REPORT REPRESENTS BUR 2 OF 2.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7324295 ↗