BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSAFITCUP GENERAL FLEXIBLE BAYONET DRILL Ø 3.2 MM SHAFT L 56

    MDR report key: 8486480 · Received April 5, 2019

    Report

    Report Number
    3005180920-2019-00241
    Event Type
    Malfunction
    Date Received
    April 5, 2019
    Date of Event
    March 8, 2019
    Report Date
    April 5, 2019
    Manufacturer
    HPF SPA
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    PRELIMINARY INVESTIGATION PERFORMED BY R&D PROJECT MANAGER: THE RECEIVED PHOTO SHOWED THE DRILL BIT BROKEN IN TWO PARTS TOWARDS THE END OF THE HELIX. IT IS NOT POSSIBLE TO DETERMINE WITH CERTAINTY THE ROOT CAUSE OF THE EVENT; A POSSIBLE CAUSE CAN BE RELATED TO A HIGH FLEXION APPLIED TO THE DRILL BIT, WHICH LED TO THE BREAKAGE.

    Description of Event or Problem · 1

    DURING THE HIP REPLACEMENT THE SURGEON DECIDED THAT HE NEEDED TO INSERT SCREWS INTO THE ACETABULUM. WHEN THE SURGEON WENT TO USE THE DRILL IT SNAPPED IN HALF. ALL OF THE DRILL BIT WAS RETRIEVED AND NO PART REMAINED INSIDE OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281539 VERSAFITCUP GENERAL FLEXIBLE BAYONET DRILL Ø 3.2 MM SHAFT L 56 SURGICAL INSTRUMENT FOR HIP LXH HPF SPA 15H9820

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other