BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIO PEDICULAR SCREWDRIVER

    MDR report key: 1881927 · Received October 11, 2010

    Report

    Report Number
    9617544-2010-00407
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    September 20, 2010
    Report Date
    September 20, 2010
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 CODES WILL BE MADE AVAILABLE FOLLOWING ENGINEERING EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ¿I WAS GETTING MY TRIO SET READY TO GO OUT FOR A CASE AND NOTICED THAT THE SELFHOLDING SCREWDRIVER SHAFT WAS BROKEN. HALF OF THE TIP HAD BROKEN OFF. I¿M NOT SURE HOW IT HAPPENED.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIO PEDICULAR SCREWDRIVER INSTRUMENT LXH STRYKER SPINE BORDEAUX NA 090994

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK