N/A 1882569HS (UDI 20763000041308)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20763000041308), received between Apr 7, 2022 and May 5, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2025Break; Break

  IT WAS REPORTED THAT THE BUR WAS BROKEN WHILE IN USE BUT NO FRAGMENTS/PIECES DETACHED FROM THE HOUSING. THE DEVICE WAS BEING RUN AT 12000 RPM. THERE WAS A PROCEDURAL DELAY OF 2 MINUTES AND THE PROCEDURE WAS COMPLETED USING BACK UP PRODUCTS. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21957953 ↗
• MalfunctionApr 7, 2022Break; Break

  IT WAS REPORTED THAT DURING PROCEDURE THE BUR BROKE INSIDE THE PATIENT NOSE. NO INTERVENTION PLANNED OR PERFORMED. NO BROKEN PIECES OF THE REPORTED PRODUCT REMAIN INSIDE THE PATIENT'S BODY. THERE WAS NO PATIENT INJURY. THE PROCEDURE WAS COMPLETED WITH BACK-UP PRODUCT AND THERE WAS NO SURGICAL DELAY. ON FOLLOW-UP IT WAS REPORTED THAT THE TIP OF THE BUR, THAT SPLINTERED FROM THE REST OF THE DEVICE, BUT WAS REMOVED. FRAGMENTS REMOVED FROM THE PATIENT WITH A CLAMP. THE BROKEN PARTS DID NOT CONTAINED IN THE HANDPIECE OR IN THE OUTER BLADE THAT PREVENTED THE FRAGMENTS FROM CONTACTING THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14048240 ↗