BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFORATOR DRIVER WITH HUDSON END

    MDR report key: 4171587 · Received October 14, 2014

    Report

    Report Number
    1045834-2014-14391
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Report Date
    September 12, 2012
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBE
    PMA / PMN Number
    PK965080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE CAME IN FOR SERVICE AND WAS REPAIRED BY TECHNICIAN. NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A LACK OF POWER. 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
    649922 PERFORATOR DRIVER WITH HUDSON END DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1