N/A 1883672HS (UDI 20763000041056)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 20763000041056), received between Nov 22, 2022 and Jul 31, 2026 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50096353 ↗
• InjuryJun 11, 2026Material Fragmentation

  IT WAS REPORTED THAT DRILL TIP BROKE OFF INTO PATIENT'S FRONTAL SINUS WHILST IN USE. THE ITEM REQUIRED DELICATE EXTRACTION AS IT HAD A SHARP POINT WHERE IT HAD BROKEN OFF IN THE INTERNAL SHAFT OF THE ITEM. INTERVENTION PERFORMED. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. THERE IS NO KNOWN PATIENT IMPACT. ADDITIONAL INFORMATION STATES THAT PERIOPERATIVE TEAM AND CAN CONFIRM THAT THE PATIENT HAD TO ENDURE ADDITIONAL ANAESTHETIC TIME, DUE TO THE ADDITIONAL DRILLING THAT WAS REQUIRED TO ENSURE ALL REMNANTS OF THE REMAINING FRAGMENTS WERE REMOVED WITHOUT INCIDENT. NO STAFF MEMBER WAS INJURED IN THIS SCENARIO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25466896 ↗
• MalfunctionJul 17, 2025Mechanical Problem; Vibration; Mechanical Problem; Vibration

  IT WAS REPORTED THAT INTRAOPERATIVELY, THE BUR DID NOT STOP WORKING; HOWEVER, THE INNER PIECE BECAME LOOSE AND STARTED COMING OUT, THOUGH NO FRAGMENTS DETACHED. THE INNER PIECE COULD NOT BE RESEATED, WHICH CAUSED THE BUR TO BECOME FLOPPY. AS A RESULT, THE BUR WAS NO LONGER USED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22531049 ↗
• MalfunctionOct 25, 2023Break; Break

  THE BUR IS FOUND BROKEN WHEN THE BLADE JUST INSERT AT THE HAND-PIECE AND START ROTATE FOR FEW SECOND, SO NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18002450 ↗
• MalfunctionJul 12, 2023Break; Overheating of Device; Break; Overheating of Device

  IT WAS REPORTED THAT DURING PROCEDURE WHEN THE DRILL WAS USED TO GRIND THE FRONTAL SINUS, THE DRILL OVERHEATED AND SHAFT BROKE. THERE WAS NO FRAGMENTS DETACHED FROM THE BUR. THE PROCEDURE WAS COMPLETED USING CONVENTIONAL SURGICAL DEVICE. NO PROCEDURE DELAY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17304020 ↗
• MalfunctionNov 22, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING FRONTAL SINUS PROCEDURE TIP OF THE BUR BROKE WHILE THE SURGEON WAS USING IT. THEY USED AN ENDOSCOPE TO REMOVE THE FRAGMENT FROM THE PATIENT, THERE WAS NO INJURY TO PATIENT. SURGERY WAS EXTENDED BY 30 MINS AND WAS COMPLETED BY BACKUP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15841641 ↗