BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM CONSOLE,SINGLE PORT,W/IRRIGA

    MDR report key: 5210554 · Received November 9, 2015

    Report

    Report Number
    1045834-2015-12431
    Event Type
    Malfunction
    Date Received
    November 9, 2015
    Date of Event
    October 27, 2015
    Report Date
    October 27, 2015
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    PK011444
    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 AND OBSERVED THAT THE DEVICE PASSED ALL OPERATIONAL SPECIFICATIONS. THEREFORE, THE REPORTED CONDITION WAS NOT CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS NOT DETERMINED. HOWEVER, DURING EVALUATION, IT WAS OBSERVED THAT THE CONNECTOR PORT ON THE DEVICE WAS ROTATED. IT WAS DETERMINED THAT THIS WAS DUE TO USER ERROR BY TWISTING THE CONNECTOR INSTEAD OF PLUGGING IT STRAIGHT IN AND OUT. 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 2 FOR THE SAME EVENT. IT WAS REPORTED THAT DURING PRE-SURGERY TESTING, IT WAS OBSERVED THAT AN E8 ERROR CODE WAS DISPLAYED WHILE THE MOTOR DEVICE AND CONSOLE DEVICE WERE IN USE TOGETHER. THERE WAS NO DELAY TO A SCHEDULED SURGICAL PROCEDURE AS IDENTICAL SPARE DEVICES WERE AVAILABLE FOR USE. 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
    742620 SYSTEM CONSOLE,SINGLE PORT,W/IRRIGA MOTOR, DRILL, ELECTRIC - CONSOLE HBC DEPUY SYNTHES POWER TOOLS NA

    Patients

    Seq Age Sex Outcome Treatment
    1