BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOOT CONTROL

    MDR report key: 3221767 · Received July 11, 2013

    Report

    Report Number
    1045834-2013-02724
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    June 20, 2013
    Report Date
    June 20, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RECEIVED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND IT WAS OBSERVED THAT THE COVERING OF THE CORD WAS CUT / TORN AND SHIELDING IS EXPOSED. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. EVIDENCE SUGGESTS THIS WAS DUE TO HANDLING ISSUES AT THE CUSTOMER SITE. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT ACCORDINGLY.(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PRE-TESTING, IT WAS OBSERVED THAT THERE WAS "TORN POWER CORD INSULATION" ON THE FOOT CONTROL DEVICE. THE REPORTER CLARIFIED THAT WIRES WERE EXPOSED. THERE WERE NO DELAYS IN THE SCHEDULED SURGICAL PROCEDURE AS AN IDENTICAL SPARE DEVICE WAS AVAILABLE. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS ALLEGED. 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
    320655 FOOT CONTROL MOTOR, DRILL, ELECTRIC-FOOT CONTROL HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1