BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFORATOR DRIVER WITH HUDSON END

    MDR report key: 4171589 · Received October 14, 2014

    Report

    Report Number
    1045834-2014-14337
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Report Date
    October 19, 2012
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBE
    PMA / PMN Number
    PK965080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING PRE-REPAIR ASSESSMENT PERFORMED BY TECHNICIAN, IT WAS NOTED THAT THE GEARS WERE DAMAGED DUE TO NORMAL WEAR. THE DEVICE WAS REPAIRED BY REPLACING SEVERAL COMPONENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE DEVICE DID NOT FUNCTION. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650347 PERFORATOR DRIVER WITH HUDSON END DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1