BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 7 SAG SAW

    MDR report key: 4131423 · Received October 1, 2014

    Report

    Report Number
    0001811755-2014-03436
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 4, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS IS IN PROGRESS; ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETED. FAILURE ANALYSIS IS IN PROGRESS; ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. SIGNS OF THIRD PARTY WORK ON THE DEVICE WERE NOTED DURING FAILURE ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY THE DEVICE DISASSEMBLED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING BACK-UP EQUIPMENT. NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY THE DEVICE DISASSEMBLED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING BACK-UP EQUIPMENT. NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611211 SYSTEM 7 SAG SAW INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1