BEUDAMED
    FDA Adverse Event Death Summary report: N

    LAG SCREW INSERTER

    MDR report key: 19248 · Received August 11, 1994

    Report

    Report Number
    33458-1994-00003
    Event Type
    Death
    Date Received
    August 11, 1994
    Date of Event
    July 31, 1994
    Report Date
    August 10, 1994
    Manufacturer
    ZIMMER PRODUCT SERVICE
    Product Code
    HXX
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AN ORTHOPEDIC SURGEON PERFORMED A HIP COMPRESSION SCREW SURGERY ON A PT ON 7/31/94. TWO DAYS LATER A GENERAL SURGEON PERFORMED SURGERY ON THE SAME PT IN AN ATTEMPT TO FIND A CAUSE OF BLEEDING, BUT COULD NOT LOCATE SOURCE. THE PT DIED ON 8/3/94THE ORTHOPEDIC SURGEON WHO PERFORMED THE HIP COMPRESSION CASE INDICATED THAT HE BELIEVES THAT THE GUIDE PIN MAY HAVE BECOME ENGAGED IN THE COMPRESSION SCREW INSERTER CAUSING THE GUIDE PIN TO BE DRIVEN INTO THE PELVIS AND STRIKING A NERVE OR MUSCLE AND CAUSE BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAG SCREW INSERTER LAG SCREW INSERTER INSTRUMENT HXX ZIMMER PRODUCT SERVICE NA 51009700

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death| O THREADED GUIDE PIN CAT. NO. 1181-020