BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.0MM TAPERED ROUTER

    MDR report key: 6239283 · Received January 10, 2017

    Report

    Report Number
    0001811755-2017-00036
    Event Type
    Malfunction
    Date Received
    January 10, 2017
    Date of Event
    December 14, 2016
    Report Date
    March 21, 2017
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HBE
    UDI-DI
    07613327096736
    PMA / PMN Number
    K143399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED ONCE THE QUALITY INVESTIGATION IS COMPLETE. ROUTER DISCARDED.

    Additional Manufacturer Narrative · 1

    IT WAS INITIALLY REPORTED THAT THE ROUTER WAS DISCARDED, A PARTIAL PIECE WAS RETURNED WITH THE ATTACHMENT. INVESTIGATION RESULTS CONCLUDED THAT AS THE ROUTER WAS LOADED WITHOUT THE ATTACHMENT. THIS COULD POTENTIALLY CAUSE THE FRACTURE OF THE ROUTER. A REVIEW OF THE ASSOCIATED ATTACHMENT IFU 5407-210-768 REV-A NOTED THE FOLLOWING WARNING; "NOTE: CUTTING ACCESSORY LABELS ARE MARKED WITH A COLOR STRIPE TO FACILITATE CUTTING ACCESSORY SELECTION. TO SELECT AN APPROPRIATE CUTTING ACCESSORY, MATCH THE COLOR STRIPE ON THE CUTTING ACCESSORY LABEL WITH THE COLOR STRIPE ON THE ATTACHMENT. WHILE ALIGNING THE DOTS ON THE ATTACHMENT AND MOTOR, SLIDE THE ATTACHMENT OVER THE CUTTING ACCESSORY AND ONTO THE MOTOR UNTIL IT SNAPS INTO PLACE. WARNING: OPERATING THE MOTOR WITHOUT THE ATTACHMENT SECURELY CONNECTED AND CUTTING ACCESSORY SECURELY LOCKED MAY RESULT IN PATIENT OR HEALTHCARE STAFF INJURY."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PRODUCT DEMONSTRATION WITH THE PI DRIVE PLUS MOTOR, THE ROUTER BROKE. IT WAS ALSO REPORTED THAT THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, AND THERE WAS NO DELAY OR ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PRODUCT DEMONSTRATION WITH THE PI DRIVE PLUS MOTOR, THE ROUTER BROKE. IT WAS ALSO REPORTED THAT THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, AND THERE WAS NO DELAY OR ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20844 3.0MM TAPERED ROUTER DRILLS, BURRS, TREPHINES & ACCESSORIES HBE STRYKER INSTRUMENTS-KALAMAZOO 16204017 07613327096736

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4)