BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGETING ARM T2 PROX. HUM.

    MDR report key: 3161090 · Received June 11, 2013

    Report

    Report Number
    0009610622-2013-00319
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 17, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-KIEL
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. DEVICE WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    DURING T2 PH SURGERY, THE SURGEON DID THE DRILL OF THE PROXIMAL SCREW HOLE OF THE NAIL. AFTERWARDS, WHEN THE SURGEON TRIED TO INSERT THE SCREW, THE SCREW CONTACTED THE EDGE OF THE SCREW HOLE OF THE NAIL. THEREFORE THE SURGEON CHANGED INSERTION OF SCREW INTO OTHER SCREW HOLE, AND COMPLETED THE OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262202 TARGETING ARM T2 PROX. HUM. INSTRUMENT LXH STRYKER OSTEOSYNTHESIS-KIEL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other