BEUDAMED
    FDA Adverse Event Other Summary report: N

    INSTRUMENT, SCREWDRIVER

    MDR report key: 664850 · Received January 11, 2006

    Report

    Report Number
    1825034-2006-00001
    Event Type
    Other
    Date Received
    January 11, 2006
    Date of Event
    December 6, 2005
    Report Date
    December 20, 2005
    Product Code
    HXX
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TOTAL HIP ARTHROPLASTY, HEX TIP SECTION OF SCREWDRIVER FRACTURED DURING INSERTION OF ACETABULAR RIM SCREW. TIP REMAINS IN THE HEX OF THE IMPLANTED SCREW COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSTRUMENT, SCREWDRIVER HXX NA 445350

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O