CONMED
Received Jun 26, 2026 · Event occurred Jun 5, 2026
Report 1017294-2026-00132 · MDR key 25633575
Device
Product problems
- Material Fragmentation
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
G3 INITIAL AWARENESS DATE WAS 6/11/26 THE REPORTED DEVICE IS BEING RETURNED TO CONMED FOR EVALUATION. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE DEVICE EVALUATION AND COMPLAINT INVESTIGATION. WE WILL CONTINUE TO MONITOR PER REGULATORY REQUIREMENTS TO HELP ENSURE PATIENT SAFETY.
Description of Event or Problem
THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, 00505900600, STERNUM SAW BLADE GUARD, WAS BEING USED IN A STERNOTOMY PROCEDURE ON (B)(6) 2026 WHEN IT WAS REPORTED, ¿BLADE GUARD BROKE OFF AND HAD TO BE RETRIEVED.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. FURTHER ASSESSMENT FOUND THAT THE FRAGMENTATION HAD FALLEN INTO THE PATIENT AND WAS RETRIEVED. THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF AN ALTERNATE DEVICE CAUSING A 5-MINUTE DELAY. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.