BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3081467 · Received April 29, 2013

    Report

    Report Number
    8030965-2013-02007
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    February 28, 2013
    Report Date
    March 28, 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 PRODUCT CODE: HWC. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM SYNTHES (B)(4) INDICATED A HOSPITAL IN (B)(6) REPORTED: DURING A DISTAL RADIUS FRACTURE SURGERY ON (B)(6) 2013: IMAGES TAKEN REVEALED THE SCREW WAS PENETRATED. AFTER REPOSITIONING AND IMPLANTING THE VA LCP 2 COLUMN DISTAL RADIUS PLATE, THE SURGEON THEN INSERTED AND LOCKED THE VA LOCKING SCREWS. IT WAS REPORTED THE SURGEON FELT THE SCREW WAS NOT LOCKED IN THE DISTAL ROW, MOST STYLOID HOLE. IMAGES TAKEN REVEALED THE SCREW WAS PENETRATED. THE SURGEON COULD REMOVE THE SCREW THROUGH THE PLATE HOLE AND DECIDED TO LEAVE THE PENETRATED SCREW AND PLATE IMPLANTED. THE SURGERY WAS COMPLETED. REPORTEDLY, THE SURGEON COMPLETED THE PROCEDURE BY THE GLOBAL TECHNICAL PROCEDURE, HE CHOSE FIXED MODE AND USED THE TORQUE LIMITER 0.8NM IN LOCK. NO FURTHER INFORMATION WAS PROVIDED. THIS IS 1 OF 2 REPORTS FOR THE SAME EVENT, COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184927 VA-LCP-2-COLUMN DRP2.4 VOLAR NARR LE SHA HRS SYNTHES GMBH 8043706

    Patients

    Seq Age Sex Outcome Treatment
    1