BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.0CM SHORT ATTACHMENT

    MDR report key: 3161368 · Received June 11, 2013

    Report

    Report Number
    1045834-2013-02395
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    April 28, 2013
    Report Date
    May 17, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE, AND THE REPORTED PROBLEM COULD NOT BE DUPLICATED OR CONFIRMED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE THE ATTACHMENT DEVICE "DID NOT WORK". THE SURGICAL PROCEDURE WAS COMPLETED WITHOUT DELAY AS AN IDENTICAL SPARE DEVICE WAS AVAILABLE. THERE WERE NO INJURIES OR MEDICAL INTERVENTION REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262550 5.0CM SHORT ATTACHMENT MOTOR, DRILL, ELECTRIC- ATTACHMENT HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1