BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREWDRIVER AXSOS T8 3.0MM LOCKING SET

    MDR report key: 1190565 · Received October 2, 2008

    Report

    Report Number
    8031020-2008-00089
    Event Type
    Malfunction
    Date Received
    October 2, 2008
    Date of Event
    September 8, 2008
    Report Date
    September 10, 2008
    Manufacturer
    STRYKER OSTEOSYNTHESIS SELZACH
    Product Code
    HXX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED, AND IF RECEIVED, WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGEON OVER TORQUED THE SCREWDRIVER AND THE TIP BROKE OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREWDRIVER AXSOS T8 3.0MM LOCKING SET INSTRUMENT HXX STRYKER OSTEOSYNTHESIS SELZACH NA N272215

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other