BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFORATOR DRIVER W/HUDSON END

    MDR report key: 4171641 · Received October 14, 2014

    Report

    Report Number
    1045834-2014-14090
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Report Date
    June 26, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBE
    PMA / PMN Number
    PK042783
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING PRE-REPAIR ASSESSMENT PERFORMED BY A TECHNICIAN, FUNCTIONAL TESTING WAS PERFORMED AND REVEALED DAMAGED GEARS. THIS WAS ATTRIBUTED TO NORMAL WEAR. VARIOUS PARTS WERE REPLACED. DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    DEVICE WAS RETURNED FOR SERVICE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650371 PERFORATOR DRIVER W/HUDSON END DRILLS, BURRS, TREPHINES & ACCESSORIES - COMPACT SPEED REDUCER HBE DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1