BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIXED DURAGUARD, 16MM

    MDR report key: 3251397 · Received July 29, 2013

    Report

    Report Number
    0001811755-2013-01775
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    July 1, 2013
    Report Date
    July 1, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT REPAIRABLE, AND THEREFORE NOT RETURNED TO THE USER FACILITY. THE REPORTED EVENT OF THE DEVICE BEING BENT WAS CONFIRMED BY THE DIAGNOSTIC TECHNICIAN. THE BUR WAS NOT ABLE TO LOAD PROPERLY INTO THE DURAGUARD DUE TO THE FOOT OF THE DURAGUARD BEING BENT. THIS DAMAGE LIKELY OCCURRED WHEN EXCESSIVE SIDE LOAD WAS APPLIED TO THE FEATURE.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED FOR EVALUATION. A FOLLOW-UP WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FIXED DURAGUAD, 16MM, WAS BENT, AND THEREFORE NOT RUNNING THE BLADE PROPERLY. THIS WAS REPORTED PRIOR TO ANY ASSOCIATED PROCEDURE. AFTER FOLLOW-UP WITH THE USER FACILITY, NO FURTHER INFORMATION REGARDING THIS EVENT COULD BE PROVIDED. NO PATIENT INVOLVEMENT, NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION, AND NO SURGICAL DELAY WERE ALLEGED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FIXED DURAGUAD, 16 MM, WAS BENT, AND THEREFORE NOT RUNNING THE BLADE PROPERLY. THIS WAS REPORTED PRIOR TO ANY ASSOCIATED PROCEDURE. AFTER FOLLOW-UP WITH THE USER FACILITY, NO FURTHER INFORMATION REGARDING THIS EVENT COULD BE PROVIDED. NO PATIENT INVOLVEMENT, NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION, AND NO SURGICAL DELAY WERE ALLEGED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353406 FIXED DURAGUARD, 16MM DRILL, SURGICAL, ENT (ELECTRIC OR PNUMATIC) INCLUDING HANDPIECE ERL STRYKER INSTRUMENTS-KALAMAZOO 13075

    Patients

    Seq Age Sex Outcome Treatment
    1