BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1/8" HEADLESS PIN

    MDR report key: 2142649 · Received June 21, 2011

    Report

    Report Number
    2249697-2011-00916
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    May 27, 2011
    Report Date
    May 30, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "DURING THE TKA, WHEN THE SURGEON WAS INSERTING THE HEADLESS PIN, IT STUCK AND BROKE INTO THE DISTAL RESECTION GUIDE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1/8" HEADLESS PIN INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other