BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNTHES

    MDR report key: 273560 · Received April 13, 2000

    Report

    Report Number
    MW1018658
    Event Type
    Malfunction
    Date Received
    April 13, 2000
    Date of Event
    April 5, 2000
    Report Date
    April 12, 2000
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING SURGICAL REPAIR OF A RIGHT FEMUR NECK FRACTURE A DSH SCREW BROKE OFF AT THE SHAFT WHILE BEING INSERTED AND AGAIN WHEN ATTEMPT WAS MADE TO REMOVE THE SCREW. THE PORTION OF THE SCREW SHAFT WHICH BROKE OFF WAS LEFT IN THE BONE TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNTHES DHS SCREW HWC SYNTHES (USA) * *

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other