CONMED 00509120100Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10845854001028), received between Feb 22, 2017 and Oct 12, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 12, 2021Material Fragmentation; Material Fragmentation

  THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE 00509120100 (QTY (B)(4) SAME LOT) WAS BEING USED DURING A MEDIUM STRAIGHT SIDE CUT ON (B)(6) 2021 WHEN IT WAS REPORTED ¿ON THE SAME SURGERY ACT, THEY BROKE 3 TIMES ON 4 UNITS BUR 5091-201 CARBIDE MICRO SIDE-CUTTING STRAIGHT MEDIUM 6 FLUTES LOT:1072359.¿ THE PROCEDURE WAS REPORTED AS HAVING BEEN COMPLETED. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION OF THE PATIENT. FURTHER ASSESSMENT INFORMATION WAS REQUESTED FROM THE REPORTER AND IT WAS FOUND THAT NO FRAGMENTS WERE LOST IN THE PATIENT. ANY SEEN FRAGMENTATION WAS REMOVED FROM THE PATIENT USING A HEMOSTAT DEVICE. 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 12614462 ↗
• MalfunctionNov 20, 2017Break; Break

  A CONMED AFFILIATE REPORTED ON BEHALF OF A USER FACILITY THAT DURING A MANDIBLE PROCEDURE, THE TIP OF A 00509120100 SIDE-CUTTING BUR BROKE. THE BROKEN TIP WAS CAPTURED BY THE SUCTION LINE. THIS DID NOT CAUSE A SIGNIFICANT DELAY AND THE PROCEDURE WAS COMPLETED AS SCHEDULED WITH NO PATIENT INJURY. THE REPORTED DEVICE WAS DISCARDED BY THE FACILITY DUE TO BIOMATERIAL STILL PRESENT ON THE DEVICE. ADDITIONAL PATIENT INFORMATION AND EVENT DETAILS HAVE NOT BEEN PROVIDED. THIS REPORT IS RAISED ON THE BASIS OF A DEVICE MALFUNCTION WITH POTENTIAL FOR PATIENT INJURY WITH RECURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7047652 ↗
• MalfunctionNov 20, 2017Break; Break

  A CONMED AFFILIATE REPORTED ON BEHALF OF A USER FACILITY THAT DURING A MANDIBLE PROCEDURE, THE TIP OF A 00509120100 SIDE-CUTTING BUR BROKE. THE BROKEN TIP WAS CAPTURED BY THE SUCTION LINE. THIS DID NOT CAUSE A SIGNIFICANT DELAY AND THE PROCEDURE WAS COMPLETED AS SCHEDULED WITH AN ALTERNATIVE DEVICE. NO PATIENT CONSEQUENCES/INJURY WERE REPORTED. THE REPORTED DEVICE WAS DISCARDED BY THE FACILITY DUE TO BIOMATERIAL STILL PRESENT ON THE DEVICE. ADDITIONAL PATIENT INFORMATION AND EVENT DETAILS HAVE NOT BEEN PROVIDED. THIS REPORT IS RAISED ON THE BASIS OF A DEVICE MALFUNCTION WITH POTENTIAL FOR PATIENT INJURY WITH RECURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7047647 ↗
• MalfunctionNov 20, 2017Break; Break

  A CONMED AFFILIATE REPORTED ON BEHALF OF A USER FACILITY THAT DURING A MANDIBLE PROCEDURE, THE TIP OF A 00509120100 SIDE-CUTTING BUR BROKE. THE BROKEN TIP WAS CAPTURED BY THE SUCTION LINE. THIS DID NOT CAUSE A SIGNIFICANT DELAY AND THE PROCEDURE WAS COMPLETED AS SCHEDULED WITH NO PATIENT INJURY. THE REPORTED DEVICE WAS DISCARDED BY THE FACILITY DUE TO BIOMATERIAL STILL PRESENT ON THE DEVICE. ADDITIONAL PATIENT INFORMATION AND EVENT DETAILS HAVE NOT BEEN PROVIDED. THIS REPORT IS RAISED ON THE BASIS OF A DEVICE MALFUNCTION WITH POTENTIAL FOR PATIENT INJURY WITH RECURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7047646 ↗
• MalfunctionFeb 22, 2017Break

  THE CUSTOMER REPORTED THAT DURING USE OF THE 1 X 5 MM SIDE CUTTING BURS, MEDIUM STRAIGHT IN A PLASTICS RHINOPLASTY PROCEDURE THE BURS BROKE OFF INSIDE THE NASAL CAVITY. THE BROKEN PORTIONS WERE REMOVED SAFELY AND THE PROCEDURE WAS OTHERWISE COMPLETED AS PLANNED WITH NO PATIENT INJURY OR SURGICAL DELAY REPORTED. DESPITE THE GOOD FAITH EFFORTS, NO ADDITIONAL EVENT INFORMATION OR PATIENT DEMOGRAPHIC INFORMATION COULD BE OBTAINED FROM THE USER FACILITY. THIS REPORT IS FILED ON THE BASIC OF POTENTIAL FOR PATIENT INJURY WITH RECURRENCE.

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 6348728 ↗