BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINK TWIST DRILL

    MDR report key: 3945655 · Received July 17, 2014

    Report

    Report Number
    3945655
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    March 7, 2014
    Report Date
    July 17, 2014
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    WHILE REAMING OUT THE FEMORAL CANAL, THE DISTAL END OF A 6MM AIRPLANE DRILL BROKE OFF IN THE DISTAL END OF THE FEMUR. SURGICAL STAFF ATTEMPTED TO RETRIEVE THE BROKEN SECTION OF THE DRILL BUT IT WAS DEEMED "UNRETRIEVABLE" BY THE STAFF. THE STAFF STATED IT WAS NOT CLOSE TO ANY NERVES OR ARTERIES AND WAS SAFELY IN THE CANAL. STAFF TAGGED THE BROKEN INSTRUMENT AND THEN PROCEEDED WITH THE CASE AS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418724 LINK TWIST DRILL PROSTHESIS, HIP, SURGICAL EQUIPMENT/DEVICE HTW WRIGHT MEDICAL TECHNOLOGY * A608086

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR