BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER ORTHOPAEDICS DRILL BIT 3.3 MM X 25 MM

    MDR report key: 8028326 · Received October 31, 2018

    Report

    Report Number
    MW5080983
    Event Type
    Malfunction
    Date Received
    October 31, 2018
    Date of Event
    October 25, 2018
    Report Date
    October 29, 2018
    Manufacturer
    HOWMEDICA OSTEONICS CORP AKA STRYKER ORTHOPAEDICS
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DRILL BIT BROKE OFF INTO ACETABULUM ATTEMPTED TO RETRIEVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863127 STRYKER ORTHOPAEDICS DRILL BIT 3.3 MM X 25 MM BIT, DRILL HTW HOWMEDICA OSTEONICS CORP AKA STRYKER ORTHOPAEDICS 21073325 SC22356H

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR