BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADRA GENERAL BROACH HANDLE

    MDR report key: 7498739 · Received May 9, 2018

    Report

    Report Number
    3005180920-2018-00314
    Event Type
    Malfunction
    Date Received
    May 9, 2018
    Date of Event
    April 9, 2018
    Report Date
    May 9, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LOT 1213194: (B)(4) ITEMS MANUFACTURED AND RELEASED 20 APRIL 2013. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, NO SIMILAR EVENT ON THE SAME LOT HAS BEEN REGISTERED. INSPECTION PERFORMED BY R&D PRODUCT MANAGER ON 09 MAY 2018. THE FORK OF MOBILE PIN IS BROKEN. NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED BASED ON THE INFORMATION AVAILABLE, HOWEVER IT IS LIKELY THAT WEAR AND "RIPETUTE" USE OF THE DEVICE CONTRIBUTED TO BREAKDOWN OF THE COMPONENT. ALSO THE PICTURE RECEIVED FROM THE DISTRIBUTOR WERE ANALYSED DURING THE INVESTIGATION.

    Description of Event or Problem · 1

    DURING THE FEMORAL PREPARATION THE INSTRUMENT MOBILE PIN BROKE. THE BREAKAGE HAPPENED DURING THE EXTRACTION OF THE HANDLE FROM THE BROACH. THE SURGERY WAS COMPLETED SUCCESSFULLY AND WITHOUT DELAY USING A BACK-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342746 QUADRA GENERAL BROACH HANDLE SURGICAL INSTRUMENT FOR HIP LXH MEDACTA INTERNATIONAL SA 1213194

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other