BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULATED DRILL 4.9MM FOR SCREWS 6.5MM LARGE A

    MDR report key: 1850358 · Received September 20, 2010

    Report

    Report Number
    8031020-2010-00121
    Event Type
    Malfunction
    Date Received
    September 20, 2010
    Date of Event
    September 5, 2010
    Report Date
    September 7, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS SELZACH
    Product Code
    HTW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS DISCARDED BY THE HOSPITAL. NO EVAL WILL BE PERFORMED. IF ADDITIONAL INFO BECOMES AVAILABLE, IT WILL BE SUBMITTED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE DRILL KEEPS BINDING ONTO THE K-WIRE AND ADVANCE THE K-WIRE FORWARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CANNULATED DRILL 4.9MM FOR SCREWS 6.5MM LARGE A IMPLANT HTW STRYKER OSTEOSYNTHESIS SELZACH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other