BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADM BALL IMPACTOR TIP

    MDR report key: 2192478 · Received June 30, 2011

    Report

    Report Number
    9616680-2011-00429
    Event Type
    Malfunction
    Date Received
    June 30, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 7, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    LXH
    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 EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "SURGEON WAS USING THE RIM IMPACTOR AND 2 ADM TRAYS HAD TO BE OPENED BECAUSE THE SURGEON SAID THE RIM IMPACTOR TIPS WERE BEATEN UP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADM BALL IMPACTOR TIP INSTRUMENT LXH STRYKER ORTHOPAEDICS CORK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other