BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGETING ARM

    MDR report key: 1861323 · Received October 4, 2010

    Report

    Report Number
    9610622-2010-00431
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    September 16, 2010
    Report Date
    September 21, 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

    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

    DURING T2 PH SURGERY, THE SURGEON ASSEMBLED THE NAIL TO TARGET DEVICE AND INSERTED THE NAIL. WHEN THE DRILLING FOR THE DISTAL SCREW HOLE WAS DONE, THE DRILL MISSED THE SCREW HOLE OF THE NAIL. THE SURGEON DID NOT FIX THE TWO DISTAL SCREWS. THE SURGERY WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TARGETING ARM INSTRUMENT LXH STRYKER OSTEOSYNTHESIS KIEL NA KHI082075

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other