BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARGE HEXAGONAL SCREWDRIVER

    MDR report key: 2901152 · Received January 8, 2013

    Report

    Report Number
    2530088-2013-00007
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Report Date
    February 27, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. IMPLANT DATE IS APPROXIMATELY (B)(6) 2011.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH LISS PLATE AND SCREW CONSTRUCT TO TREAT A FEMUR FRACTURE, ON AN UNKNOWN DATE, ABOUT (B)(6) 2011. ON AN UNKNOWN DATE, THE POST-OPERATIVE X-RAYS REVEALED A MAL-UNION. ON (B)(6) 2012 PATIENT RETURNED TO THE O.R. AND ALL HARDWARE WAS EXPLANTED. DURING THIS PROCEDURE, THE SCREW DRIVER THE SURGEON WAS USING BROKE, AND THE TIP OF IT STAYED IN THE HEAD OF THE SCREW. PATIENT WAS ALSO TREATED FOR POSSIBLE INFECTION. THIS IS 2 OF 12 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9740 LARGE HEXAGONAL SCREWDRIVER SCREWDRIVER HXX SYNTHES BRANDYWINE A4JK477

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR SCREWS, PLATE