BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM QUICK CONNECT THREADED

    MDR report key: 2861200 · Received November 2, 2012

    Report

    Report Number
    2249697-2012-02170
    Event Type
    Malfunction
    Date Received
    November 2, 2012
    Date of Event
    October 8, 2012
    Report Date
    October 8, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME PATIENT/EVENT AS MFR #2249697-2012-02169.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, THE NUT ENGAGES THE OFFSET IMPACTOR STRIPPED AND THE INNER LOCK ALSO STRIPPED MAKING IT IMPOSSIBLE TO SEAT AND RELEASE A CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM QUICK CONNECT THREADED INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA F5M10994

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other