BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 6 SAGITTAL SAW

    MDR report key: 3952981 · Received July 23, 2014

    Report

    Report Number
    0001811755-2014-02638
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 30, 2014
    Report Date
    June 30, 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

    THE REPORTED DISASSEMBLY WAS CONFIRMED BY A MANUFACTURER REPAIR TECHNICIAN THROUGH VISUAL INSPECTION. POTENTIAL CAUSES FOR THE REPORTED EVENT INCLUDE A MATERIAL FATIGUE ISSUE OR IMPACT.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A SURGICAL PROCEDURE AT THE USER FACILITY, THE DEVICE DISASSEMBLED. 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 PRIOR TO A SURGICAL PROCEDURE AT THE USER FACILITY, THE DEVICE DISASSEMBLED. 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
    430618 SYSTEM 6 SAGITTAL SAW INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1