BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGET ADAPTER

    MDR report key: 1850157 · Received September 22, 2010

    Report

    Report Number
    9610622-2010-00398
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Date of Event
    September 8, 2010
    Report Date
    September 8, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING T2 SCN SURGERY, THE SURGEON DRILLED TO THE DISTAL SCREW HOLE OF THE NAIL (LOCKING POSITION OF TARGET ARM WAS "2"). THE SURGEON INSERTED THE LOCKING SCREW. THE SCREW HAD COME OUT OF THE DISTAL SCREW HOLE OF THE NAIL. SURGEON CONFIRMED BY X-RAY IMAGE AFTER INSERTING THE SCREW. THE SURGEON REMOVED THE LOCKING SCREW AND THE DRILLING WAS DONE BY A FREEHAND TECHNIQUE AND THE SCREW WAS INSERTED AGAIN. THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TARGET ADAPTER INSTRUMENT LXH STRYKER OSTEOSYNTHESIS KIEL NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Other