BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCOLADE STEM INSERTER/EXTRACTOR

    MDR report key: 2924094 · Received December 14, 2012

    Report

    Report Number
    2249697-2012-02689
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    November 21, 2012
    Report Date
    November 26, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, THREADS ON INSERTER ARE STRIPPED AND COULD NOT BE USED. PATIENT WAS ON THE OPERATING ROOM BUT HOSPITAL HAD ANOTHER INSERTER AVAILABLE AND THERE WAS NO DELAY IN SURGERY OR ADVERSE CONSEQUENCE TO THE PATIENT OR USER. THIS WAS A PRIMARY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCOLADE STEM INSERTER/EXTRACTOR INSTRUMENT JDI STRYKER ORTHOPAEDICS MAHWAH NA BPVL04U

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other