BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 2992905 · Received March 7, 2013

    Report

    Report Number
    2520274-2013-01338
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    November 26, 2012
    Report Date
    February 8, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    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. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    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 2 OF 2 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98095 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR