BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.4MM VA LOCKING SCREW STARDRIVE 16MM

    MDR report key: 2251169 · Received August 10, 2011

    Report

    Report Number
    1719045-2011-00544
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 15, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWC
    PMA / PMN Number
    K103243
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED.

    Description of Event or Problem · 1

    DURING AN ORIF OF THE LEFT DISTAL RADIUS THE SURGEON IMPLANTED THE 2.4MM VA-LCP 2-CLMN VLR DSTL. RADIUS PLATE AND WAS INSERTING THE SCREWS. SURGEON COULD NOT GET TWO 2.4MM VA LOCKING SCREWS INTO THE STYLOID HOLES. SURGEON DID NOT IMPLANT ANY SCREWS IN THE TWO HOLES. PROCEDURE WAS COMPLETED. THE PLATE HAS 6 HOLES IN THE HEAD AND FOUR HOLES IN THE SHAFT. PLATE REMAINS IMPLANTED MISSING TWO SCREWS. THIS IS THREE OF THREE REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2.4MM VA LOCKING SCREW STARDRIVE 16MM 2.4MM VA LOCKING SCREW HWC SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR PLATE