CONMED 00509222800Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10845854002964), received between May 17, 2023 and May 17, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (1 report).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 17, 2023Material Fragmentation; Material Fragmentation

  THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE 00509222800, 4MM ROUND BUR, LONG, CARBIDE, 5EA, WAS BEING USED DURING AN UNKNOWN PROCEDURE ON 12APR23 WHEN IT WAS REPORTED ¿SHORTLY AFTER THE CUSTOMER STARTED USING THIS BUR, IT WAS REPORTED THAT THE CUTTING EDGE CHIPPED.¿. FURTHER ASSESSMENT QUESTIONING FOUND THAT IS UNKNOWN IF THE DEVICE FRAGMENTED INTO THE SURGICAL SITE. IT WAS ALSO REPORTED THAT "PATIENT AND USER ARE UNLIKELY TO BE HARMED.". THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE ¿BACKUP BUR¿ AND IT IS UNKNOWN IF THERE WAS A DELAY IN THE PROCEDURE. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16944903 ↗