BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGETING ARM

    MDR report key: 2253816 · Received August 10, 2011

    Report

    Report Number
    9610622-2011-00362
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 20, 2011
    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

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    DURING T2 PH SURGERY, THE SURGEON ASSEMBLED THE NAIL TO TARGET DEVICE AND INSERTED THE NAIL TO THE PATIENT BONE. AFTERWARDS, DRILLING FOR THE DISTAL SCREW HOLE OF THE NAIL WAS DONE. THE LOCKING SCREW WAS INSERTED. WHEN THE SURGEON CONFIRMED BY X-RAY, THE SCREW MISSED THE HOLE. THEREFORE, THE SCREW WAS REMOVED AND REINSERTED BY FREEHAND TECHNIQUE. THE SURGERY WAS COMPLETED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other