CONMED 00509120200Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10845854008409), received between Feb 27, 2023 and Feb 27, 2023 — classified as 2 injuries.

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

• InjuryFeb 27, 2023Material Fragmentation; Material Fragmentation

  INTERNATIONAL COMPLAINTS REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, 00509120200, 1.5 X 10MM SIDECUTTING BUR, MEDIUM, STRAIGHT 1256148, WAS BEING USED ON 01FEB23 DURING A BILATERAL OSTEOTOMY PROCEDURE WHEN IT WAS REPORTED ¿DRILLS (2 UNITS) BROKE DURING PROCEDURE ONE DRILL BIT NOT FOUND AWAITING XRAY TO CONFIRM LOCATION IS NOT IN THE PATIENT.¿ FURTHER ASSESSMENT QUESTIONING FOUND THAT ¿WHILE PERFORMING A BILATERAL OSTEOTOMY, TWO CONMED 00509120200 SIDE CUTTING BURS BROKE. THE SURGICAL TEAM WERE ABLE TO RETRIEVE THE BROKEN PART FROM THE FIRST BUR. HOWEVER, THE SURGICAL TEAM WERE NOT ABLE TO FIND THE PART THAT BROKE ON THE SECOND BUR. THE SURGICAL SITE WAS INVESTIGATED BUT NOTHING COULD BE FOUND, IT WAS ASSUMED THE BROKEN PIECE GOT SUCKED UP IN THE SUCTION. THE SURGICAL SITE ACCESS WAS REPORTED AS BEING QUITE DIFFICULT. THIS REPORT IS BEING RAISED DUE TO TWO BURS BREAKING CONSECUTIVELY. POST OPERATIVE ORTHOPANTOMOGRAM WAS CONDUCTED, THE DRILL BIT TIP WAS NOT FOUND ON IMAGING. NO PATIENT INJURY REPORTED¿. THE FIRST DRILL BIT WAS RETRIEVED WITH THE USE OF ARTERY FORCEPS. THE SECOND DRILL BIT WAS NOT RETRIEVED BUT CONFIRMED BY OPG XRAY THAT THE FRAGMENT WAS NOT LEFT IN THE PATIEN

  Patient problems: Foreign Body In Patient

  MAUDE report 16444486 ↗
• InjuryFeb 27, 2023Material Fragmentation; Material Fragmentation

  INTERNATIONAL COMPLAINTS REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, 00509120200, 1.5 X 10MM SIDECUTTING BUR, MEDIUM, STRAIGHT 1237750, WAS BEING USED ON 01FEB23 DURING A BILATERAL OSTEOTOMY PROCEDURE WHEN IT WAS REPORTED ¿DRILLS (2 UNITS) BROKE DURING PROCEDURE ONE DRILL BIT NOT FOUND AWAITING XRAY TO CONFIRM LOCATION IS NOT IN THE PATIENT.¿ FURTHER ASSESSMENT QUESTIONING FOUND THAT ¿WHILE PERFORMING A BILATERAL OSTEOTOMY, TWO CONMED 00509120200 SIDE CUTTING BURS BROKE. THE SURGICAL TEAM WERE ABLE TO RETRIEVE THE BROKEN PART FROM THE FIRST BUR. HOWEVER, THE SURGICAL TEAM WERE NOT ABLE TO FIND THE PART THAT BROKE ON THE SECOND BUR. THE SURGICAL SITE WAS INVESTIGATED BUT NOTHING COULD BE FOUND, IT WAS ASSUMED THE BROKEN PIECE GOT SUCKED UP IN THE SUCTION. THE SURGICAL SITE ACCESS WAS REPORTED AS BEING QUITE DIFFICULT. THIS REPORT IS BEING RAISED DUE TO TWO BURS BREAKING CONSECUTIVELY. POST OPERATIVE ORTHOPANTOMOGRAM WAS CONDUCTED, THE DRILL BIT TIP WAS NOT FOUND ON IMAGING. NO PATIENT INJURY REPORTED¿. THE FIRST DRILL BIT WAS RETRIEVED WITH THE USE OF ARTERY FORCEPS. THE SECOND DRILL BIT WAS NOT RETRIEVED BUT CONFIRMED BY OPG XRAY THAT THE FRAGMENT WAS NOT LEFT IN THE PATIEN

  Patient problems: Foreign Body In Patient

  MAUDE report 16444466 ↗