BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO SAGITTAL SAW

    MDR report key: 2837152 · Received October 11, 2012

    Report

    Report Number
    1811755-2012-03803
    Event Type
    Malfunction
    Date Received
    October 11, 2012
    Date of Event
    September 18, 2012
    Report Date
    September 19, 2012
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS AT THIS TIME; IT IS NOT POSSIBLE TO DETERMINE THE CASE OF THE REPORTED MALFUNCTION WITHOUT AN EVALUATION OF THE DEVICE. ADDITIONAL INFORMATION WILL BE SUBMITTED WHEN THE DEVICE IS RECEIVED, AND IF ADDITIONAL INFORMATION IS RECEIVED AND REQUIRES REPORTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE ON A SHOULDER AT THE USER FACILITY, THE SAW WAS SMOKING WITH NO VISIBLE FLAMES AND OVERHEATING. BACK-UP EQUIPMENT WAS USED TO COMPLETE THE PROCEDURE. NO CLINICALLY SIGNIFICANT DELAY, NO ADVERSE CONSEQUENCES AND NO MEDICAL INTERVENTION WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO SAGITTAL SAW HBE STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK