BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRONIC FOOT CONTROL W/DIR ONLY

    MDR report key: 3203698 · Received July 3, 2013

    Report

    Report Number
    1045834-2013-02693
    Event Type
    Malfunction
    Date Received
    July 3, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 12, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE. THE REPORTED CONDITION WAS DUPLICATED AND CONFIRMED. EVIDENCE INDICATED THIS WAS DUE TO IMPROPER HANDLING. 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 PRE-TESTING THE FOOT CONTROL DEVICE HAD A DAMAGED PLUG. ACCORDING TO THE REPORT, THE PLUG WAS "OUT OF ROUND SHAPE, AND COULD NOT BE SEATED INTO THE CONTROL CONSOLE PORT". THE DEVICE WAS NOT BEING USED IN SURGERY. THERE WERE NO DELAYS IN ANY PLANNED SURGICAL PROCEDURES AS A SPARE IDENTICAL DEVICE WAS AVAILABLE FOR USE. 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
    305857 ELECTRONIC FOOT CONTROL W/DIR ONLY MOTOR, DRILL, ELECTRIC - FOOT CONTROL HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1