CONMED 00509122500Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10845854001370), received between Feb 17, 2026 and Feb 17, 2026 — classified as 2 malfunctions.

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. 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.

• MalfunctionFeb 17, 2026Material Fragmentation

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE 00509122500, ROUND BUR, MEDIUM, 2.4 MM DEVICE WAS USED DURING A TOOTH EXTRACTION PROCEDURE ON (B)(6) 2026, AND ¿BUR SNAPPED DURING EXTRACTION¿. THE PROCEDURE WAS COMPLETED WITH THE USE OF AN ALTERNATE DEVICE AND A DELAY OF TWO MINUTES. FURTHER ASSESSMENT FOUND ¿THE BUR FRAGMENTED ONLY INTO 2 PIECES. IT BROKE IN HALF. 1 FRAGMENT REMAINED WAS RETRIEVED FROM PATIENT AND THE OTHER REMAINED IN SURGARITOME. NO OTHER IMPORTANT INFORMATION". THERE WAS NO REPORT OF INJURY, MEDICAL/SURGICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24365344 ↗
• MalfunctionFeb 17, 2026Material Fragmentation

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE 00509122500, ROUND BUR, MEDIUM, 2.4 MM DEVICE WAS USED DURING A TOOTH EXTRACTION PROCEDURE ON (B)(6) 2026, AND ¿BUR BROKE DURING TOOTH EXTRACTION.¿. THE PROCEDURE WAS COMPLETED WITH THE USE OF AN ALTERNATE DEVICE AND A DELAY OF TWO MINUTES. FURTHER ASSESSMENT FOUND THE DEVICE "FRAGMENTED ONLY INTO 2 PIECES. ONE PART STILL INSIDE SURGAIRTOME AND ONE PIECE FALLING INTO SURGICAL AREA. FRAGMENT WAS RECOVERED.¿. THERE WAS NO REPORT OF INJURY, MEDICAL/SURGICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24363557 ↗