BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEG DRILL SIZE 1 - 2

    MDR report key: 1850361 · Received September 20, 2010

    Report

    Report Number
    2249697-2010-01241
    Event Type
    Malfunction
    Date Received
    September 20, 2010
    Date of Event
    August 11, 2010
    Report Date
    August 26, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    HTW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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, "DURING A PKR CASE INSTRUMENTS JAMMED AND LOCKED UP INSIDE EACH OTHER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEG DRILL SIZE 1 - 2 INSTRUMENT HTW STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other