BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM CONSOLE,SINGLE PORT,W/IRRIGA

    MDR report key: 3853846 · Received June 6, 2014

    Report

    Report Number
    1045834-2014-12151
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    PK011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND THE REPORTED CONDITION WAS NOT CONFIRMED. THEREFORE, AN ASSIGNABLE ROOT CAUSE WAS NOT DETERMINED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO SURGERY, IT WAS DISCOVERED THAT THE CONSOLE DEVICE WAS WORKING INTERMITTENTLY. THE REPORTER FURTHER CLARIFIED THAT THE DEVICE DID NOT DISPLAY THE ROTATIONS PER MINUTE (RPMS) OR ERROR MESSAGES. THE SYSTEM HAD TO BE STARTED AND RESTARTED. THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AS A SPARE IDENTICAL DEVICE WAS 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
    332567 SYSTEM CONSOLE,SINGLE PORT,W/IRRIGA MOTOR, DRILL, ELECTRIC - CONSOLE HBC DEPUY SYNTHES POWER TOOLS NA

    Patients

    Seq Age Sex Outcome Treatment
    1