BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRONIC FOOT CONTROL W/DIR ONLY

    MDR report key: 3971312 · Received July 31, 2014

    Report

    Report Number
    1045834-2014-12515
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 17, 2014
    Report Date
    July 17, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    PK080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE:THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE. A VISUAL ASSESSMENT WAS PERFORMED WHICH FOUND THAT THE CORD WAS TORN EXPOSING THE WIRES. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETEREMINED TO BE DUE TO MISHANDLING, WHICH IS MISUSE AND/OR ABUSE. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO SURGERY, IT WAS DISCOVERED THAT THE WIRES OF THE FOOT CONTROL DEVICE WERE EXPOSED. THERE WERE NO DELAYS TO THE SCHEDULED SURGICAL PROCEDURE AS AN IDENTICAL SPARE DEVICE WAS AVAILABLE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. 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
    446882 ELECTRONIC FOOT CONTROL W/DIR ONLY MOTOR, DRILL, ELECTRIC - FOOT CONTROL HBC DEPUY SYNTHES POWER TOOLS NA

    Patients

    Seq Age Sex Outcome Treatment
    1