BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW, CANNULATED

    MDR report key: 7384884 · Received March 30, 2018

    Report

    Report Number
    7384884
    Event Type
    Malfunction
    Date Received
    March 30, 2018
    Date of Event
    March 20, 2018
    Report Date
    March 21, 2018
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE DOCTOR INSERTED A 4.0 CANNULATED SCREW INTO THE CALCANEUS WITH A HAND-HELD SCREW DRIVER. WHILE HE WAS TWISTING THE SCREW IN THE SCREW BROKE OFF LEAVING THE THREADED END IN THE BONE WITHOUT REDUCTION OF THE FRACTURE. THE DOCTOR WAS ABLE TO RETRIEVE THE BROKEN PIECE AFTER NUMEROUS ATTEMPTS. THE SCREW HAD BROKEN INTO THREE PIECES. THE BROKEN SCREW PIECES WERE PLACED ALONGSIDE A COMPLETE SCREW AND IT LOOKED LIKE ALL THE PIECES WERE PRESENT. THE SCREW WAS FROM AN ARTHREX LOANER CANNULATED SCREW SET, 4.0MM X 60MM PARTIAL THREAD. SCREW PART NUMBER AR-8740-60. THE PATIENT WAS UNDER AN ADDITIONAL THIRTY MINUTES WHILE THE SURGEON WAS RETRIEVING THE BROKEN SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229732 SCREW, CANNULATED HWC ARTHREX, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR