BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIO CONNECTOR 3.5 MM HEX SOCKET FOR TORQUE WRENCH

    MDR report key: 1111956 · Received August 11, 2008

    Report

    Report Number
    9617544-2008-00077
    Event Type
    Malfunction
    Date Received
    August 11, 2008
    Date of Event
    July 28, 2008
    Report Date
    July 23, 2008
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    HXC
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    DURING SURGERY, THE TIP OF THE HEX SOCKET BROKE WHILE FINAL TIGHTENING. THE FINAL TIGHTENING WAS COMPLETED WHEN THE TIP BROKE. THE BROKEN TIP REMAINED IN THE CONNECTOR PLACED IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIO CONNECTOR 3.5 MM HEX SOCKET FOR TORQUE WRENCH INSTRUMENT HXC STRYKER SPINE BORDEAUX NA 04C08

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other