BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORDLESS DRIVER 3

    MDR report key: 3173251 · Received June 17, 2013

    Report

    Report Number
    0001811755-2013-01403
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 31, 2013
    Report Date
    June 3, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HRX
    PMA / PMN Number
    K943323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION HAS BEEN COMPLETED. INVESTIGATION IS IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    UPON DISASSEMBLY FOR VISUAL INSPECTION A DAMAGED E-BOX WAS FOUND.

    Description of Event or Problem · 1

    WHILE TESTING THE CORDLESS DRIVER 3 BEFORE A PROCEDURE IT WAS REPORTED THAT THE DEVICE CONTINUES TO RUN EVEN THOUGH THE FOOTSWITCH IS OFF. HOWEVER, IT SHOULD BE NOTED THAT THIS DEVICE DOES NOT USE A FOOT SWITCH TO OPERATE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    WHILE TESTING THE CORDLESS DRIVER 3 BEFORE A PROCEDURE IT WAS REPORTED THAT THE DEVICE CONTINUES TO RUN EVEN THOUGH THE FOOTSWITCH IS OFF. HOWEVER, IT SHOULD BE NOTED THAT THIS DEVICE DOES NOT USE A FOOT SWITCH TO OPERATE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274383 CORDLESS DRIVER 3 ARTHROSCOPE HRX STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1