CONMED 00509223600Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10845854001257), received between Sep 27, 2018 and Jul 24, 2025 — classified as 2 malfunctions.

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

• MalfunctionJul 24, 2025Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE THAT THE 00509223600, OVAL BUR, LONG, CARBIDE, 4 X 8 MM DEVICE WAS BEING USED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED ¿DURING PROCEDURE, TIP BROKE OF BUR BROKE OFF. BROKEN TIP RECOVERED, AND NEW PRODUCT OPENED FOR USE.¿. THE PROCEDURE WAS COMPLETED WITH THE USE OF AN ALTERNATE DEVICE. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22586260 ↗
• MalfunctionSep 27, 2018Break; Break

  ON BEHALF OF THE CUSTOMER THE DISTRIBUTOR REPORTED AN ISSUE WITH ITEM 00509223600, 4 X 8MM OVAL BUR, LONG, CARBIDE, 5EA. IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2018, WHILE CUTTING OF THE SCREW HEAD, THE BUR WAS BROKEN AT THE JOINT PART OF HEAD AND SHAFT. ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE BROKEN PIECE WAS RETRIEVED BY HAND WITH NO IMPACT TO THE PATIENT. ALL PIECES OF THE BROKEN BUR WERE REMOVED FROM THE PATIENT AND NO PATIENT OR USER INJURY WAS REPORTED. THE SURGERY WAS SUCCESSFULLY COMPLETED USING A BACK-UP BUR WITH NO FURTHER ISSUES AND NO DELAY. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7915335 ↗