BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM

    MDR report key: 23267649 · Received October 10, 2025

    Report

    Report Number
    3000327445-2025-00007
    Event Type
    Malfunction
    Date Received
    October 10, 2025
    Date of Event
    July 11, 2025
    Report Date
    October 10, 2025
    Manufacturer
    ORTHOPEDIATRICS CANADA ULC
    Product Code
    HTO
    PMA / PMN Number
    K020885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303899 SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM SLIM REAMER ØX.XMM HTO ORTHOPEDIATRICS CANADA ULC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other