BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT Ø2.0MM X 122MM AO FITTING FOR 2.7MM SCREW

    MDR report key: 3421929 · Received October 22, 2013

    Report

    Report Number
    0008031020-2013-00380
    Event Type
    Malfunction
    Date Received
    October 22, 2013
    Date of Event
    September 27, 2013
    Report Date
    September 30, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-SELZACH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF THE DEVICE OR ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. DEVICE WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    DEVICE: 703701 DRILL BIT Ø2.0MM X 122MM AO FITTING FOR 2.7MM SCREW. CUSTOMER REPORTED THE DRILL BIT IS BROKEN, THE PRODUCT IS SUPPLIED BY SCL VIA CONSIGNMENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541948 DRILL BIT Ø2.0MM X 122MM AO FITTING FOR 2.7MM SCREW INSTRUMENT LXH STRYKER OSTEOSYNTHESIS-SELZACH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other