N/A 1885076HSE (UDI 00613994233196)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613994233196), received between Jun 26, 2017 and Mar 15, 2021 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 15, 2021Break; Material Fragmentation; Break; Material Fragmentation

  NO FRAGMENTS LEFT IN THE PATIENT'S BODY. BURS WERE USED IN THE SAME EVENT. THE USER REPORTED THAT A REASONABLE SMALL FORCE WAS APPLIED WHEN DRILLING THEN IT BROKE. THERE WAS NO PATIENT OR STAFF IMPACT. NO FRAGMENT FELL ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11484978 ↗
• MalfunctionJul 27, 2018Break; Use of Device Problem; Use of Device Problem

  A HEALTHCARE PROFESSIONAL REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE BUR WASN'T WORKING WELL AND THE TOOL BROKE AT THE END WHEN TRYING TO DETACH IT FROM THE MICRODEBRIDER. THE TOOL WAS REPLACED AND THE MICRODEBRIDER WAS CHANGED. IT WAS NOTED THAT PATIENT SYMPTOMS WERE UNKNOWN AND THERE WAS NO INJURY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7728422 ↗
• MalfunctionJun 26, 2017Break; Break

  THE SALES REP REPORTED THAT THE BUR BROKE A FEW MINUTES AFTER IT WAS CONNECTED TO THE HANDPIECE. THE BREAK DID NOT RESULT IN A FRAGMENT(S). THERE WAS NO PATIENT INJURY AND NO DELAY TO THE SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6666876 ↗