BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.0MM HEADLESS COMPRESSION SCREW-SHORT THREAD 2

    MDR report key: 2930478 · Received January 22, 2013

    Report

    Report Number
    2520274-2013-00510
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    December 27, 2012
    Report Date
    December 27, 2012
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    PMA / PMN Number
    K050636
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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

    DURING A BUNIONECTOMY, THE SURGEON DRILLED OVER THE THREADED GUIDE WIRE FOR THE HEADLESS COMPRESSION SCREW. AS THE SURGEON WAS INSERTING THE SCREW, THE BONE FELL OUT OF REDUCTION. SURGEON REMOVED THE SCREW AND MET SOME RESISTANCE IN REMOVING. SURGEON USED ANOTHER K-WIRE, DRILL BIT AND HEADLESS COMPRESSION SCREW IN ORDER TO REPOSITION AND INSERT THE SCREW. THE SECOND ATTEMPT INCREASED THE SURGERY TIME ABOUT 15 MINUTES. A POST OP X-RAY SHOWED A FRAGMENT FROM THE FIRST SCREW WAS LEFT IN THE PT'S BONE. IT WAS NOT DETERMINED WHETHER THE FRAGMENT WAS FROM THE K-WIRE, DRILL BIT OR THE SCREW. SURGEON COMPLETED THE PROCEDURE; PT IS REPORTEDLY RECOVERING WELL. THIS IS 1 OF 3 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29240 3.0MM HEADLESS COMPRESSION SCREW-SHORT THREAD 2 HEADLESS COMPRESSION SCREW HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DRILL BIT| THREADED GUIDE WIRE| SCREW