BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 7 SAG SAW

    MDR report key: 2955053 · Received February 11, 2013

    Report

    Report Number
    0001811755-2013-00243
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    January 30, 2013
    Report Date
    January 30, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HWE
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED FOR EVALUATION; ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETED. THE DEVICE WAS RECEIVED FOR EVALUATION; ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS NOT CONFIRMED. BASED ON A REVIEW OF COMPLIANT TRENDING, POSSIBLE CAUSES INCLUDE USING THE HANDPIECE BEYOND THE SPECIFIED DUTY CYCLE OR AN INTERMITTENT ISSUE WITH THE E-BOX THAT CAUSED HIGHER CURRENT DRAW RESULTING IN EXCESS HEAT GENERATION, HOWEVER, THIS WAS NOT OBSERVED.

    Description of Event or Problem · 1

    THE SYSTEM 7 SAGITTAL SAW WAS SENT FOR EVALUATION DUE TO OVERHEATING DURING TESTING CONDUCTED BY THE MANUFACTURER SALES REPRESENTATIVE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE DEVICE.

    Description of Event or Problem · 1

    THE SYSTEM 7 SAGITTAL SAW WAS SENT FOR EVALUATION DUE TO OVERHEATING DURING TESTING CONDUCTED BY THE MANUFACTURER SALES REPRESENTATIVE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58367 SYSTEM 7 SAG SAW INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1