BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VA-LCP-2-COLUMN DRP2.4 VOLAR NARROW LE S

    MDR report key: 2841258 · Received November 21, 2012

    Report

    Report Number
    8030965-2012-01312
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 18, 2012
    Report Date
    October 25, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    PMA / PMN Number
    K092556
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A DEVICE HISTORY RECORDS REVIEW HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM (B)(4) INDICATED A HOSPITAL IN (B)(6) REPORTED: DURING THE DISTAL RADIUS FRACTURE SURGERY, THE LOCKING SCREW MENTIONED ABOVE WENT THROUGH THE MOST DISTAL HOLE AT THE RADIAL SIDE OF THE PLATE MENTIONED ABOVE, WHEN THE SURGEON INSERTED IT USING A GUIDING BLOCK AND A TORQUE LIMITING DRIVER BY A FIXED ANGLE METHOD AFTER DRILLING AND MEASUREMENT. WHILE INSERTING HE FELT NO RESISTANCE AND HEARD NO CLICK. SURGEON REMOVED THE SCREW FROM THE PLATE. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VA-LCP-2-COLUMN DRP2.4 VOLAR NARROW LE S VA-LCP-2-COLUMN HWC SYNTHES GMBH 7982970

    Patients

    Seq Age Sex Outcome Treatment
    1 PLATE, SCREW