BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREWDRIVER BLADE, T7, AO

    MDR report key: 2061497 · Received March 16, 2011

    Report

    Report Number
    8010177-2011-00072
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    February 22, 2011
    Report Date
    February 21, 2011
    Manufacturer
    STRYKER OSTEOSYNTHESIS FREIBURG
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROCESS BUT NOT YET COMPLETE.

    Description of Event or Problem · 1

    IT WAS FOUND THAT THE TIP OF THE SCREW DRIVER BLADE WAS BROKEN WHEN IT WAS CHECKED UPON THE INSPECTION OF THE RETURNED LONER KIT FROM THE HOSPITAL. IT WAS CONFIRMED WITH THE HOSPITAL THAT THE TIP OF THE BROKEN SCREW DRIVER WAS REMOVED FORM THE PT'S BODY. NO DETAILED INFORMATION ON HOW THE BLADE WAS BROKEN WAS AVAILABLE FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREWDRIVER BLADE, T7, AO INSTRUMENT LXH STRYKER OSTEOSYNTHESIS FREIBURG NA AA06

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK