BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRONIC FOOT CONTROL W/DIR ONLY

    MDR report key: 4130405 · Received September 30, 2014

    Report

    Report Number
    1045834-2014-12972
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 18, 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
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND OBSERVED THAT THERE WAS A CUT IN THE CABLE WITH EXPOSED WIRES. IT WAS DETERMINED THAT THIS WAS DUE TO MISHANDLING OF THE DEVICE BY ALLOWING THE CABLE TO COME IN CONTACT WITH A SHARP OBJECT. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO MISHANDLING, WHICH IS MISUSE AND/OR ABUSE AND POSSIBLY USER ERROR. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SERVICE AND REPAIR/PRE-TESTING, IT WAS OBSERVED THAT THE FOOT CONTROL DEVICE HAD A CUT IN THE CABLE WITH EXPOSED WIRES. THIS EVENT IS NOT RELATED TO SURGERY. THERE WAS NO PATIENT INVOLVEMENT. 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
    608854 ELECTRONIC FOOT CONTROL W/DIR ONLY MOTOR, DRILL, ELECTRIC - FOOT CONTROL HBC DEPUY SYNTHES POWER TOOLS NA

    Patients

    Seq Age Sex Outcome Treatment
    1