BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO SAGITTAL SAW

    MDR report key: 3002689 · Received March 13, 2013

    Report

    Report Number
    0001811755-2013-00517
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 13, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PRELIMINARY EVALUATION OF THE DEVICE HAS BEEN COMPLETED AND SUBMITTED TO THE QUALITY ENGINEER FOR FURTHER ANALYSIS. A FOLLOW-UP REPORT WILL BE FILED WHEN THE FINAL INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    UPON DISASSEMBLY FOR VISUAL INSPECTION CORROSION WAS FOUND ON THE MOTOR AND THE SOCKETS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MICRO SAGGITAL SAW RAN WITHOUT USER ACTIVATION DURING A ROUTINE EQUIPMENT EVALUATION AT THE USER FACILITY, BY A MANUFACTURER'S SERVICE TECHNICIAN. THERE WAS NO PATIENT INVOLVEMENT, AND THERE WERE NO USER INJURIES OR ADVERSE CONSEQUENCES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MICRO SAGGITAL SAW RAN WITHOUT USER ACTIVATION DURING A ROUTINE EQUIPMENT EVALUATION AT THE USER FACILITY, BY A MANUFACTURER'S SERVICE TECHNICIAN. THERE WAS NO PATIENT INVOLVEMENT, AND THERE WERE NO USER INJURIES OR ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104700 MICRO SAGITTAL SAW DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1