CONMED 00507112000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10845854000281), received between Sep 13, 2022 and Jan 10, 2025 — 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. 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.

• MalfunctionJan 10, 2025Material Fragmentation; Material Fragmentation

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE 00507112000, OSCILLATOR BLADE, 19.5 X 95 X 0.9 MM (.035") DEVICE WAS USED IN A PROCEDURE ON (B)(6) 2024, AND ¿DURING A TOTAL KNEE TODAY ONE OF THE OSCILLATING BLADES BROKE. ALL PARTS WERE ACCOUNTED FOR AND THE PATIENT WAS NOT INJURED.¿ FURTHER ASSESSMENT FOUND THAT "TWO PIECES OF THE METAL BROKE OFF THE END THAT ATTACHED TO THE SAW". THE DEVICE FRAGMENTED AND FELL INTO THE SURGICAL SITE, WITH "ALL PIECES WERE RETRIEVED ¿ THREE IN TOTAL." THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE SAME DEVICE AND A DELAY OF APPROXIMATELY 5 MINUTES. THERE WAS NO INJURY, MEDICAL/SURGICAL INTERVENTION OR EXTENDED HOSPITALIZATION REQUIRED FOR THE PATIENT, WHO WAS "DISCHARGED TO HOME". 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 21129432 ↗
• MalfunctionSep 13, 2022Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, 00507112000, 19.5 X 95 X 0.9MM (.035INCH) OSCILLATOR BLADE WAS BEING USED ON (B)(6) 2022 DURING AN UNKNOWN PROCEDURE AND BROKEN SAW BLADE. PULLING METALS PIECES OUT OF PATIENT. ALL PIECES RECOVERED PROCEDURE COMPLETED. PATIENT REQUIRED AN X-RAY TO CONFIRM ALL PIECED REMOVED. THERE WAS NO IMPACT OR INJURY TO THE PATIENT. THERE WAS NO REPORT OF MEDICAL/SURGICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THERE WAS A 20-30 MINUTE DELAY TO THE PROCEDURE. 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 15410478 ↗