BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO SAGITTAL SAW

    MDR report key: 4092913 · Received September 16, 2014

    Report

    Report Number
    0001811755-2014-03259
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 19, 2014
    Report Date
    August 19, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K112593
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUTTING ACCESSORY ORIGINALLY REPORTED UNDER THIS MDR REPORT WAS RETURNED FOR EVALUATION AND THE FAILURE IS CONFIRMED. UPON EVALUATION OF THE ORIGINALLY LISTED CONCOMITANT DEVICE ((B)(4) LOT 0812302123) IT WAS FOUND THAT THE LINK FINS ON THE SAW WERE CRACKED, WHICH CAN LEAD TO THE REPORTED EVENT. THIS CUTTING ACCESSORY ((B)(4) LOT UNKNOWN) IS NOW LISTED AS CONCOMITANT DEVICE IN SECTION D.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS AVAILABLE FOR RETURN. A FOLLOW UP REPORT WILL BE FILED ONCE THE QUALITY INVESTIGATION IS COMPLETE. DEVICE NOT YET RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BLADE BROKE AT THE MOUNT DURING A PROCEDURE. IT WAS FURTHER REPORTED THAT ALL PIECES OF THE BLADE WERE ACCOUNTED FOR. THERE WERE NO ADVERSE CONSEQUENCES OR SURGICAL DELAY AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BLADE BROKE AT THE MOUNT DURING A PROCEDURE. IT WAS FURTHER REPORTED THAT ALL PIECES OF THE BLADE WERE ACCOUNTED FOR. THERE WERE NO ADVERSE CONSEQUENCES OR SURGICAL DELAY AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572547 MICRO SAGITTAL SAW DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL STRYKER INSTRUMENTS-KALAMAZOO 0812302123

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4) LOT 0812302123| (B)(4) LOT UNKNOWN