SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM

Additional Manufacturer Narrative

THE HOSPITAL REPRESENTATIVE REPORTED THAT THE SLIM CANNULATED REAMERS, RECEIVED AS PART OF A RENTAL/LOANER TRAY AND CHECKED INTO THE HOSPITAL, WERE FOUND TO CONTAIN OLD BONE DURING SURGERY, RENDERING THEM CONTAMINATED. THE DISTRIBUTOR WAS CONTACTED FOR CLARIFICATION REGARDING THE CLEANING AND REPROCESSING OF THE INSTRUMENT. THEY CONFIRMED THAT THE REAMERS HAD BEEN INSPECTED BY TWO DIFFERENT INDIVIDUALS AND CLEANED PRIOR TO SHIPMENT TO THE NEXT SURGERY. THE ROOT CAUSE WAS TRACED TO THE DISTRIBUTOR, WHO DID NOT DETECT IN TIME THAT THE CANNULATION OF THE REAMER WAS CONTAMINATED DURING THE PREVIOUS SURGERY. THE DISTRIBUTOR ACKNOWLEDGED THAT THE POST-SURGERY INSPECTION PROCESS NEEDS TO BE IMPROVED TO PREVENT RECURRENCE. A CORRECTIVE AND PREVENTIVE ACTION (CAPA) HAS ALREADY BEEN INITIATED BY THE MANUFACTURER TO STRENGTHEN THE POST-SURGERY INSPECTION PROCESS ACROSS ALL DISTRIBUTORS, AND IT IS CURRENTLY ONGOING. NOTE: THIS MDR WAS ORIGINALLY SUBMITTED AS MFR #3000327-2025-00007 ON SEPTEMBER 18, 2025, BUT WAS REJECTED BY CDRH DUE TO AN INCORRECT FEI NUMBER IN THE ESUBMITTER FORM. IT IS NOW RESUBMITTED WITH THE CORRECT FEI (3000327445). CAPA INITIATED TO ADDRESS THE ISSUE.

Description of Event or Problem

THE HOSPITAL REPRESENTATIVE REPORTED THAT THE SLIM CANNULATED REAMERS, RECEIVED AS PART OF A RENTAL/LOANER TRAY AND CHECKED INTO THE HOSPITAL, WERE FOUND TO CONTAIN OLD BONE DURING SURGERY, RENDERING THEM CONTAMINATED.