BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELIANCE T HANDLE

    MDR report key: 2852863 · Received November 27, 2012

    Report

    Report Number
    9617544-2012-00508
    Event Type
    Malfunction
    Date Received
    November 27, 2012
    Date of Event
    October 30, 2012
    Report Date
    October 30, 2012
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    KWQ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    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 AN ENGINEERING EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "A PIECE OF METAL BROKE OFF ON THE BOTTOM INSIDE OF THE T HANDLE THAT CONNECTS TO A SHAVER OR PADDLE, NOT EXACTLY SURE HOW THIS HAPPENED. HOWEVER THIS DID NOT IMPACT THE CASE OR THE LENGTH OF THE SURGERY. WE HAD ANOTHER T HANDLE AVAILABLE TO USE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RELIANCE T HANDLE INSTRUMENT KWQ STRYKER SPINE BORDEAUX NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK