CONMED 00509322800Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10845854002490), received between Mar 8, 2018 and Mar 27, 2019 — 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. How this data works · Data updated Oct 13, 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.

• MalfunctionMar 27, 2019Break; Break

  THE CUSTOMER REPORTED THAT THE 00509322800, 4MM ROUND BUR, LOOSENED FROM THE DRILL ROD. THE TIP OF THE BUR WAS RETRIEVED FROM THE PATIENT. A REQUEST FOR ADDITIONAL INFORMATION HAS BEEN MADE, BUT NO INFORMATION WAS RECEIVED TO DATE. THERE IS NO REPORTED INJURY OR DELAY OF SURGERY. THIS REPORT IS BEING RAISED BASED ON DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8457223 ↗
• MalfunctionMar 8, 2018Break; Break

  A CUSTOMER REPORTED DURING USE A 00509322800 ROUND BUR BROKE WHILE CUTTING. PHOTOGRAPHIC EVIDENCE SHOWS THE BUR BROKE AT THE SHAFT. ALL DETACHED BUR HEAD WAS REMOVED AND A 10-MINUTE SURGICAL DELAY ENSUED TO OBTAIN AND READY AN ALTERNATIVE DEVICE. NO PATIENT INJURY WAS REPORTED. TO DATE, ADDITIONAL PATIENT AND EVENT INFORMATION HAVE NOT BEEN MADE AVAILABLE. THIS REPORT IS RAISED ON THE BASIS OF A REPORTED DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY WITH RECURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7324287 ↗