BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.5MM HEX ADJ SCRWDRVR BLADE

    MDR report key: 2771618 · Received September 25, 2012

    Report

    Report Number
    MW5027113
    Event Type
    Malfunction
    Date Received
    September 25, 2012
    Date of Event
    September 17, 2012
    Report Date
    September 25, 2012
    Manufacturer
    SYNTHES
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING CLOSURE OF A CABG THE TIP OF THE SCREWDRIVER BROKE OFF AND WAS NOT FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4.5MM HEX ADJ SCRWDRVR BLADE SCREWDRIVER HXX SYNTHES U153475

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other