BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRAIGHT MEDIUM SABER ATTACHMENT

    MDR report key: 3903809 · Received June 30, 2014

    Report

    Report Number
    0001811755-2014-02341
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 5, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT THAT THE BUR WAS SLIPPING AND THE ATTACHMENT WOULD NOT HOLD THE BUR INTO PLACE WAS NOT DUPLICATED AND NO FAILURES WERE CONFIRMED. UPON DISASSEMBLY, THERE WERE NO OBSERVED FAILURES THAT COULD LEAD TO THE REPORTED EVENT. THE DEVICE WAS SCRAPPED AT THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED AFTER THE QUALITY INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STRAIGHT MEDIUM SABER ATTACHMENT WOULD NOT HOLD THE BUR DURING A PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A BACK UP DEVICE. THERE WERE NO PATIENT OR USER INJURIES, AND NO ADVERSE CONSEQUENCES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STRAIGHT MEDIUM SABER ATTACHMENT WOULD NOT HOLD THE BUR DURING A PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A BACK UP DEVICE. THERE WERE NO PATIENT OR USER INJURIES, AND NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380561 STRAIGHT MEDIUM SABER ATTACHMENT DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL STRYKER INSTRUMENTS-KALAMAZOO 14112

    Patients

    Seq Age Sex Outcome Treatment
    1