BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.3MM SPIRAL ROUTER

    MDR report key: 6562692 · Received May 12, 2017

    Report

    Report Number
    0001811755-2017-01236
    Event Type
    Malfunction
    Date Received
    May 12, 2017
    Date of Event
    April 1, 2017
    Report Date
    May 12, 2017
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K143399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS CONCLUDED THE PRESENCE OF ABRASIVE WEAR ALONG THE FLUTE EDGES SUGGESTS THERE MAY HAVE BEEN CONTACT WITH ANOTHER METAL INSTRUMENT WHILE IN USE. THIS CONTACT MAY HAVE RESULTED IN THE FRACTURE OBSERVED ON THE RETURNED DEVICE. THE IFU FOR THE ATTACHMENT (5407-210-768 REV-A) HAS THE FOLLOWING WARNING; "DO NOT LET THE SPINNING CUTTING ACCESSORY COME INTO CONTACT WITH RETRACTORS OR OTHER METAL TOOLS. METAL SHAVINGS COULD DETACH FROM THE EQUIPMENT AND FALL INTO THE SURGICAL SITE."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SERVICE CONDUCTED AT THE MANUFACTURER A BROKEN ROUTER WAS FOUND INSIDE THE ATTACHMENT. 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
    345900 2.3MM SPIRAL ROUTER DRILLS, BURRS, TREPHINES & ACCESSORIES HBE STRYKER INSTRUMENTS-KALAMAZOO UNKNOWN

    Patients

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