BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VA-LCP-2-COLUMN DRP2.4 VOLAR NARR LE SHA

    MDR report key: 3131711 · Received May 29, 2013

    Report

    Report Number
    8030965-2013-02453
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 8, 2013
    Report Date
    May 1, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    PMA / PMN Number
    K092556
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: (B)(4). THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES GMBH REPORTS AN EVENT IN (B)(4) AS FOLLOWS: DURING SURGERY FOR A DISTAL RADIUS FRACTURE ON (B)(6) 2013, THE SURGEON INSERTED VARIABLE ANGLE (VA) LOCKING SCREWS IN THE PROXIMAL ROW MOST STYLOID HOLES WITH A GUIDING BLOCK. THE GUIDING BLOCK WAS REMOVED. THE SCREWS WERE LOCKED WITH A DRIVER AND TORQUE LIMITER. ONE SCREW WOULD NOT STOP SPINNING. EVENTUALLY, THIS SCREW PENETRATED THE PLATE HOLE. AFTER LOCKING THE OTHER SCREWS, THE SURGEON WAS ABLE TO LOCK THIS SCREW AS WELL. ALL SCREWS AND PLATE ARE IMPLANTED IN THE PATIENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234284 VA-LCP-2-COLUMN DRP2.4 VOLAR NARR LE SHA HRS SYNTHES GMBH 8070551

    Patients

    Seq Age Sex Outcome Treatment
    1