BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFORATOR DRIVER W/HUDSON END

    MDR report key: 3811302 · Received October 11, 2013

    Report

    Report Number
    1045834-2013-13329
    Event Type
    Malfunction
    Date Received
    October 11, 2013
    Date of Event
    November 2, 2012
    Report Date
    November 5, 2012
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBE
    PMA / PMN Number
    K042783
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY DEPUY SYNTHES POWER TOOLS. THE DEVICE WAS EVALUATED FOR "NOT LOCKING INTO MOTOR" AND CONFIRMED. DURING THE PRE-REPAIR DIAGNOSTIC ASSESSMENT, THE UNIT WAS FOUND TO HAVE A BENT DRIVE SHAFT AS WELL AS IT WAS UNABLE TO BE DISASSEMBLED. IF ADD'L INFO BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM USA, STATING THAT THE DEVICE WAS "NOT LOCKING INTO MOTOR." IT IS KNOWN THAT THE EVENT OCCURRED DURING SURGERY. IT IS ALSO KNOWN THAT THERE WAS NO PT OR USER INJURY OR MEDICAL INTERVENTION. IT IS ALSO KNOWN THAT THERE WAS NO SURGICAL DELAY RELATED TO THIS OCCURRENCE. NO ADD'L INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524148 PERFORATOR DRIVER W/HUDSON END DRILLS, BURRS, TREPHINES & ACCESSORIES - COMPACT SPEED REDUCER HBE DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1