BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VA-LCP-2-COLUMN DRP2.4 VOLAR NARROW R SH

    MDR report key: 2924451 · Received January 22, 2013

    Report

    Report Number
    8030965-2013-00189
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 25, 2012
    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. 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A DISTAL RADIUS FRACTURE PROCEDURE, AFTER REPOSITIONING AND IMPLANTING THE VA LCP PLATE, THE SURGEON DRILLED THE BONE THROUGH THE GUIDING BLOCK AND QUICK DRILL SLEEVE. HE SLOWLY INSERTED AND LOCKED THE VA LOCKING SCREW THOUGH THE GUIDING BLOCK IN A POSITIONING HOLE. IT WAS REPORTED THE SURGEON INSERTED THE SCREW CAREFULLY AND THE SCREW PENETRATED EASILY IN THE PROXIMAL ROW, MOST STYLOID HOLE. THE SURGEON TRIED TO REMOVE THE SCREW THROUGH THE HOLE, BUT HE WAS NOT ABLE TO REMOVE THE SCREW. THE PLATE AND SCREWS REMAINS IMPLANTED IN THE PATIENT. THE PROCEDURE WAS COMPLETED. THE SURGEON CHOSE FIXED MODE AND USED THE TORQUE LIMITER 0.8NM IN LOCK. HE DID NOT USE POWER TOOL DURING INSERTION. THE TOQUE VALUE WAS CHECKED BEFORE SHIPPING AND CLEARED TESTING. THIS IS 1 OF 2 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31132 VA-LCP-2-COLUMN DRP2.4 VOLAR NARROW R SH VA LCP 2 COLUMN DISTAL RADIUS PLATE HRS SYNTHES GMBH 7987374

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR SCREW