BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 7 SAG SAW

    MDR report key: 3842671 · Received June 2, 2014

    Report

    Report Number
    0001811755-2014-02005
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 14, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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.

    Additional Manufacturer Narrative · 1

    THE REPORTED OVERHEATING OF THE DEVICE WAS DUPLICATED BY A MANUFACTURER REPAIR TECHNICIAN THROUGH FUNCTIONAL EVALUATION. UPON DISASSEMBLY, IT WAS FOUND THAT THE DRIVE LINK WAS LOOSE, WHICH CAN LEAD TO THE REPORTED EVENT AND CAN BE CAUSED BY A MATERIAL FATIGUE ISSUE OR IMPACT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY, THE DEVICE WAS OVERHEATING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. 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 WAS OVERHEATING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. 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
    320769 SYSTEM 7 SAG SAW INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1