BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN PRODUCT - 3.0 AXSOS SCREWDRIVER

    MDR report key: 1082451 · Received July 22, 2008

    Report

    Report Number
    8031020-2008-00060
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    June 27, 2008
    Report Date
    June 27, 2008
    Manufacturer
    STRYKER OSTEOSYNTHESIS SELZACH
    Product Code
    HXX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO HAS BEEN REQUESTED AND IF REC'D, WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "SURGEON WENT THROUGH 3 AXSOS SCREWDRIVERS. ALL THREE BROKE AT THE TIP".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN PRODUCT - 3.0 AXSOS SCREWDRIVER INSTRUMENT HXX STRYKER OSTEOSYNTHESIS SELZACH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other