N/A 1882960Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20681490047283), received between Jul 12, 2019 and Jul 12, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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.

• MalfunctionJul 12, 2019Material Separation; Material Separation

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE TIP OF TWO (2) BURS BROKE OFF DURING THE PROCEDURE. THERE WAS NO DELAY TO THE PROCEDURE AS A RESULT OF THIS EVENT. IT WAS NOTED THAT THERE WAS NO BROKEN PIECE(S) THAT WAS LEFT INSIDE THE PATIENT'S BODY. THERE WAS NO PATIENT IMPACT OR INJURY. ON FOLLOW-UP, IT WAS REPORTED BY THE MANUFACTURER REPRESENTATIVE THAT THE TIP BROKE OFF MOST LIKELY DUE TO THE USE OF TOO MANY RPM; THE MAXIMUM FOR THE BUR IS 6.000 RPM AND THE HANDPIECE OR CONSOLE CAN GO UP TO 30.000 RPM. THE CUSTOMER WAS NOT ABLE TO CHECK THE RPM THAT WAS BEING USED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8784946 ↗
• MalfunctionJul 12, 2019Material Separation; Material Separation

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE TIP OF TWO (2) BURS BROKE OFF DURING THE PROCEDURE. THERE WAS NO DELAY TO THE PROCEDURE AS A RESULT OF THIS EVENT. IT WAS NOTED THAT THERE WAS NO BROKEN PIECE(S) THAT WAS LEFT INSIDE THE PATIENT'S BODY. THERE WAS NO PATIENT IMPACT OR INJURY. ON FOLLOW-UP, IT WAS REPORTED BY THE MANUFACTURER REPRESENTATIVE THAT THE TIP BROKE OFF MOST LIKELY DUE TO THE USE OF TOO MANY RPM; THE MAXIMUM FOR THE BUR IS 6.000RPM AND THE HANDPIECE OR CONSOLE CAN GO UP TO 30.000RPM. THE CUSTOMER WAS NOT ABLE TO CHECK THE RPM THAT WAS BEING USED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8784742 ↗