BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T25 STARDRIVE SHAFT FOR MATRIX

    MDR report key: 2100243 · Received May 16, 2011

    Report

    Report Number
    1719045-2011-00257
    Event Type
    Malfunction
    Date Received
    May 16, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 26, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED. SUBJECT DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED. INVESTIGATION IS ONGOING; NO CONCLUSION CAN BE DRAWN AS NO DEVICE WAS RETURNED. REVIEW OF THE MANUFACTURING RECORDS HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    DURING A SCOLIOSIS SURGERY, THE SURGEON TRIED TO LOOSEN THE MATRIX LOCKING CAP AFTER FINAL TIGHTENING USING THE MATRIX T25 STARDRIVE SHAFT STANDARD AND THE PANGEA TORQUE LIMITING HANDLE. UPON TRYING TO LOOSEN THE CAP WITH COUNTER TORQUE, THE SCREWDRIVER TIP BROKE. ALL FRAGMENTS OF THE TIP WERE RETRIEVED. PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 T25 STARDRIVE SHAFT FOR MATRIX T25 STARDRIVE SHAFT HXX SYNTHES MONUMENT NA 6457218

    Patients

    Seq Age Sex Outcome Treatment
    1 NI MATRIX LOCKING CAP| PANGEA TORQUE LIMITING HANDLE