CONMED 00507116100Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10845854006382), received between Nov 20, 2025 and Feb 23, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 23, 2026Material Fragmentation

  THE CUSTOMER REPORTED THAT THE 00507116100 OSCILLATOR BLADE, 25.4 X 90 X 1.27 MM (.050"), DEVICE WAS BEING USED ON (B)(6) 2026 DURING AN UNKNOWN PROCEDURE WHEN IT WAS REPORTED ¿TODAY WE HAD A 5071-161 BREAK FROM LOT: 1506918.¿. FURTHER ASSESSMENT FOUND THAT THE DEVICE DID FRAGMENT INTO THE SURGICAL SITE AND WAS REMOVED. 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 24414753 ↗
• MalfunctionJan 21, 2026Material Fragmentation

  THE CUSTOMER REPORTED THAT THE DEVICE, 00507116100, OSCILLATOR BLADE, 25.4 X 90 X 1.27 MM (.050"), WAS BEING USED DURING A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED, ¿TOTAL KNEE REPLACEMENT WAS IN PROGRESS WHEN WE NOTICED A PIECE OF METAL LODGED IN THE TIBIAL BONE.". THE ¿POWER TOOL AS IT WAS THE LAST EQUIPMENT USED IN THE TIBIA¿ WAS CHECKED AND ¿CLOSE INSPECTION SHOWS THAT TWO (BOTH ENDS) OF THE SAW BLADE TEETH HAD COME OFF.¿ ¿THE KNEE JOINT WAS WASHED NUMEROUS TIMES IN AN ATTEMPT TO FLUSH THE METAL PIECE, BUT WITH NEGATIVE RESULTS.¿ ¿THE SURGEON DECIDED TO GIVE UP THE SEARCH AND WROTE IN HIS OPERATION NOTES ABOUT THE INCIDENT.¿ ¿POST-OPERATIVE X-RAY SHOWS NO METAL PIECE IS LEFT ON THE PATIENT'S KNEE.¿ THERE REPORTER STATES THAT THERE IS NO METAL LEFT IN THE PATIENT¿S KNEE CONFIRMED BY X-RAY. THE PROCEDURE WAS COMPLETED AS PLANNED. 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 24129434 ↗
• MalfunctionNov 20, 2025Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE 00507116100 OSCILLATOR BLADE, 25.4 X 90 X 1.27 MM (.050") DEVICE WAS BEING USED DURING A TOTAL KNEE REPLACEMENT PROCEDURE ON AN UNKNOWN DATE WHEN IT WAS REPORTED ¿ONE OF THE END BLADE TEETH CAME OFF DURING TOTAL KNEE REPLACEMENT SURGERY.¿. IT WAS ALSO REPORTED ¿BROKEN SAW BLADE TOOTH REMOVED FROM PATIENT AS CONFIRMED BY X-RAY.¿ THE PROCEDURE WAS COMPLETED AND 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 23603760 ↗