BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VA-LCP-2-COLUMN DRP2.4 VOLAR LE SHAFT 3H

    MDR report key: 2841259 · Received November 21, 2012

    Report

    Report Number
    8030965-2012-01311
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 18, 2012
    Report Date
    October 25, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    PMA / PMN Number
    K083694
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PLATE WAS NOT SENT BACK FOR INVESTIGATION AND WITHOUT THE INVOLVED PLATE WE ARE NOT ABLE TO DETERMINE THE CAUSE OF THIS OCCURRENCE. THEREFORE A FINAL CONCLUSION IS BECAUSE OF THE DAMAGE AT THE RECEIVED SCREW AND WITHOUT THE INVOLVED PLATE NOT POSSIBLE. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A DEVICE REPORT FROM OBERDORF INDICATES A HOSPITAL IN JAPAN REPORTED: DURING A COLLES FRACTURE SURGERY SURGEON WAS USING A GUIDE BLOCK TO INSERT A VA LOCKING SCREW INTO A VA LCP PLATE AFTER DRILLING AND USING A TORQUE LIMITER. THE SCREW WENT THROUGH THE HOLE IN THE SECOND ROW AT THE RADIAL SIDE OF THE PLATE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. 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 LE SHAFT 3H VA-LCP-2-COLUMN PLATE HRS SYNTHES GMBH 7836979

    Patients

    Seq Age Sex Outcome Treatment
    1 PLATE, SCREW