BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SD/PD LONG CURVED

    MDR report key: 4162035 · Received October 10, 2014

    Report

    Report Number
    0001811755-2014-03552
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    September 11, 2014
    Report Date
    September 12, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K112593
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF A BROKEN BUR WAS NOT CONFIRMED. DURING THE EVALUATION OF THE ORIGINALLY LISTED CONCOMITANT DEVICE ((B)(4) LOT 14099 - SD/PD LONG CURVED ATTACHMENT), THIS DEVICE COULD NOT ACCEPT A BUR DURING TESTING. IT WAS FOUND THAT THIS DEVICE HAD A DENTED BEARING GUIDE, A DENTED BEARING GUIDE WILL PREVENT A BUR FROM BEING INSERTED INTO THE ATTACHMENT. THE ASSOCIATED CUTTING ACCESSORY (UNKNOWN INS BUR, UNKNOWN LOT #) IS NOW LISTED AS THE CONCOMITANT DEVICE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DRILL BIT BROKE OFF INSIDE OF THE ATTACHMENT DURING TESTING. IT WAS FURTHER REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT IN THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DRILL BIT BROKE OFF INSIDE OF THE ATTACHMENT DURING TESTING. IT WAS FURTHER REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643875 SD/PD LONG CURVED DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL STRYKER INSTRUMENTS-KALAMAZOO 14099

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN INS BUR, UNKNOWN INS LOT #| (B)(4)LOT 14099