BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET SCREWDRIVER, FLEXIBLE SHAFT 4 MM

    MDR report key: 1193513 · Received October 8, 2008

    Report

    Report Number
    9610622-2008-00186
    Event Type
    Malfunction
    Date Received
    October 8, 2008
    Date of Event
    September 8, 2008
    Report Date
    September 15, 2008
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HXX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "RUBBER COATING ON FLEXIBLE SHAFT WAS TORN DURING INSERTION OF SET SCREW."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SET SCREWDRIVER, FLEXIBLE SHAFT 4 MM INSTRUMENT HXX STRYKER OSTEOSYNTHESIS KIEL NA K628208

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other