BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRIC SYSTEMS FOOT CONTROL

    MDR report key: 6113068 · Received November 18, 2016

    Report

    Report Number
    1045834-2016-13262
    Event Type
    Malfunction
    Date Received
    November 18, 2016
    Date of Event
    November 11, 2016
    Report Date
    November 11, 2016
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    GTIN IS UNAVAILABLE AS THE PRODUCT MADE PRIOR TO COMPLIANCE DATE; (B)(4). AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND DETERMINED THAT THE REPORTED CONDITION OF THE DEVICE HAVING E5 ERROR CODE COULD NOT BE CONFIRMED. THEREFORE, AN ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, IT WAS FURTHER OBSERVED THAT THE DEVICE DID NOT WORK AND THE BASE PLATE WAS LOOSE WITH THE WRONG SCREWS HOLDING IT ON AND WAS MISSING THE REST COVER. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO AN UNAUTHORIZED REPAIR WHICH IS MISUSE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 4 FOR THE SAME EVENT: IT WAS REPORTED THAT DURING AN UNSPECIFIED SPINE SURGERY, IT WAS DISCOVERED THAT WHEN THE FOOT CONTROL DEVICE, CONSOLE DEVICE AND MOTOR DEVICE WERE BEING USED TOGETHER, AN E5 ERROR CODE WAS OBSERVED. IT WAS REPORTED THAT A SECOND MOTOR DEVICE WAS USED AND DID NOT WORK. IT WAS REPORTED THAT THERE WAS A FIVE MINUTE DELAY AND NO SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS REPORTED THAT THE USER USED A DIFFERENT OPTION AND THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THE REPORTER DID NOT PROVIDE ANY INFORMATION REGARDING THE DIFFERENT OPTION USED TO COMPLETE THE PROCEDURE. THERE WAS 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
    764031 ELECTRIC SYSTEMS FOOT CONTROL MOTOR, DRILL, ELECTRIC - FOOT CONTROL HBC DEPUY SYNTHES POWER TOOLS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 CONSOLE DEVICE| MOTOR DEVICES