BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFORATOR DRIVER WITH HUDSON END

    MDR report key: 4171647 · Received October 14, 2014

    Report

    Report Number
    1045834-2014-14025
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Report Date
    January 1, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBE
    PMA / PMN Number
    PK965080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING PRE-REPAIR ASSESSMENT PERFORMED BY TECHNICIAN, WAS NOTED THAT THE GEARS WERE DAMAGED DUE TO LACK OF INAPPROPRIATE CLEANING AND/OR MAINTENANCE. ADDITIONALLY, THE SHAFT WORE OUT AND THE HOUSING WAS DAMAGED, CLEANING AGENTS REMAINDERS WERE PRESENT. DEVICE WAS INSPECTED, AND REPAIRED BY REPLACING A FEW COMPONENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE DEVICE DID NOT HAVE ENOUGH POWER. THIS IS REPORT 1 OF 1 FOR EVENT # COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650373 PERFORATOR DRIVER WITH HUDSON END DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1