BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VA-LCP-2-COLUMN DRP2.4 VOLAR NARR R SHAF

    MDR report key: 2992899 · Received March 7, 2013

    Report

    Report Number
    8030965-2013-00786
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    November 26, 2012
    Report Date
    February 8, 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. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. THE DEVICE HISTORY RECORD REVIEW REPORTED THE FOLLOWING: 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 PROCEDURE ON (B)(6) 2012 THE SURGEON INSERTED AN UNKNOWN SCREW FOR THE MOST DISTAL ROW WHILE USING A GUIDING BLOCK. REPORTEDLY WHEN THE SURGEON TIGHTENED THE SCREW ON THE MOST RADIAL SIDE THE SCREW WAS NOT LOCKED WITH THE PLATE. TAKING A FURTHER LOOK THE SCREW PENETRATED THE PLATE HOLE AND BECAME BURIED IN THE BONE. THE SURGEON TRIED TO REMOVE THE BURIED SCREW WITH A SCREWDRIVER BUT IT COULD NOT BE REMOVED. THIS RESULTED IN THE SURGEON SUTURING WITHOUT REMOVING THE SCREW. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98094 VA-LCP-2-COLUMN DRP2.4 VOLAR NARR R SHAF HRS SYNTHES GMBH 8024410

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR