BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW-IN GUIDE TO GUIDE THREADS

    MDR report key: 7154332 · Received December 28, 2017

    Report

    Report Number
    MW5074277
    Event Type
    Injury
    Date Received
    December 28, 2017
    Date of Event
    December 27, 2017
    Report Date
    December 27, 2017
    Manufacturer
    STRYKER
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING ORIF OF FRACTURED FEMUR, SCREW IN GUIDE TO STRYKER AIMING GUIDE THREADS BROKE OFF IN THE PLATE. GUIDE PART NUMBER 703534; ANOTHER NUMBER ON DEVICE IS K965423, DR. (B)(6) ALERTED AS WELL AS STRYKER REP. THREADS RETAINED IN PLATE AND UNABLE TO BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    929822 SCREW-IN GUIDE TO GUIDE THREADS SCREW-IN GUIDE TO GUIDE THREADS HWC STRYKER 703534

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention