BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL BATTERY DRIVE

    MDR report key: 3872968 · Received June 13, 2014

    Report

    Report Number
    1045834-2014-12270
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 30, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HWE
    PMA / PMN Number
    PEXEMPT
    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. (B)(4) EVALUATED THE DEVICE AND THE REPORTED CONDITION WAS DUPLICATED AND CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO INTERNAL MOTOR OR (ECU) ELECTRONIC CONTROL UNIT FAILURE DUE TO USAGE WEAR OVER TIME. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO SURGERY, IT WAS OBSERVED THE SMALL BATTERY DRIVE WILL NOT RUN. THERE WERE NOT DELAYS TO THE SCHEDULED SURGICAL PROCEDURE AS AN IDENTICAL SPARE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO INJURIES REPORTED. 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
    349524 SMALL BATTERY DRIVE INSTR.SURGICAL. ORTHOPEDIC.AC-POWERED MOTOR/ACCESS & ATTACH HWE DEPUY SYNTHES POWER TOOLS 2495

    Patients

    Seq Age Sex Outcome Treatment
    1