BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOX CHISEL

    MDR report key: 2061978 · Received March 18, 2011

    Report

    Report Number
    2249697-2011-00339
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 22, 2011
    Report Date
    February 23, 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
    TX, US
    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, "WHEN SURGEON WAS PUTTING DOWN BOX CHISEL TO MAKE THE CUT, HE STRUCK AN ACL SCREW AND CHIPPED THE END OF THE CHISEL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOX CHISEL INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other