LIBERATOR
Received Jun 30, 2026 · Event occurred Jun 11, 2026
Report 1017294-2026-00133 · MDR key 25663723
Device
Product problems
- Material Fragmentation
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
G3: INITIAL AWARENESS DATE WAS 12JUN2026. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION AND REVIEW. HOWEVER, THE COMPLAINT INVESTIGATION IS NOT COMPLETE AT THIS TIME. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE COMPLAINT INVESTIGATION. WE WILL CONTINUE TO MONITOR PER REGULATORY REQUIREMENTS TO HELP ENSURE PATIENT SAFETY.
Description of Event or Problem
THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE 25.50016 RASP LIBERATOR KNIFE II, 4.75 X 149 MM, DEVICE WAS BEING USED ON (B)(6) 2026 DURING A SHOULDER LABRUM REPAIR PROCEDURE WHEN IT WAS REPORTED WAS REPORTED ¿ONE UNIT OF RASP LIBERATOR KNIFE HAD DEFECT WHEREBY IT WAS BROKEN AFTER A SINGLE USE AT THE SHOULDER JOINT.¿. FURTHER ASSESSMENT QUESTIONING FOUND THAT THE DEVICE FRAGMENTED INTO THE SURGICAL SITE AND WAS RETRIEVED WITH AN ARTHROSCOPIC GRASPER. THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF AN ALTERNATE DEVICE 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.