BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUDIBLE TORQUE WRENCH

    MDR report key: 1841224 · Received September 7, 2010

    Report

    Report Number
    9617544-2010-00330
    Event Type
    Malfunction
    Date Received
    September 7, 2010
    Date of Event
    July 23, 2010
    Report Date
    July 27, 2010
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    HXC
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF MADE AVAILABLE, WILL BE REPORTED IN A SUPPLEMENTAL. METHOD, RESULT, AND CONCLUSION WILL BE MADE AVAILABLE FOLLOWING ENGINEERING EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "THE HEX TIP OF THE TORQUE WRENCH BROKE OFF INTO FEMALE HEX OF THE BLOCKER WHILE FINAL TIGHTENING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUDIBLE TORQUE WRENCH INSTRUMENT HXC STRYKER SPINE BORDEAUX NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR