BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HLN SCRDRI 3.5MM SELF RETAIN

    MDR report key: 423420 · Received October 17, 2002

    Report

    Report Number
    9610622-2002-00087
    Event Type
    Malfunction
    Date Received
    October 17, 2002
    Report Date
    September 16, 2002
    Manufacturer
    STRYKER TRAUMA GMBH
    Product Code
    HXX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED DURING EXTRACTION OF THE SCREW, THE TIP OF THE SCREWDRIVER BROKE. THE BROKEN TIP WAS NOT RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HLN SCRDRI 3.5MM SELF RETAIN INSTRUMENT HXX STRYKER TRAUMA GMBH NA K388010

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other