BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.3MM TAPERED ROUTER

    MDR report key: 6307058 · Received February 7, 2017

    Report

    Report Number
    0001811755-2017-00502
    Event Type
    Malfunction
    Date Received
    February 7, 2017
    Date of Event
    January 13, 2017
    Report Date
    February 16, 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

    CATALOG NUMBER UPDATED FROM UNKNOWN TO 5407FA2023. INVESTIGATION RESULTS INDICATE THAT THE LEG WAS BENT ON THE ASSOCIATED ATTACHMENT (5407FA2000, (B)(4)). THE BENT LEG MAY HAVE CONTACTED THE ROUTER CAUSING IT TO BREAK. THE ATTACHMENT LEG CAN BECOME BENT OR BROKEN DUE TO EXCESSIVE LOAD BEING APPLIED. THE IFU FOR THE ATTACHMENT (5407-210-768 REV-A) HAS THE FOLLOWING WARNING; "DO NOT APPLY EXCESSIVE PRESSURE, SUCH AS BENDING OR PRYING, WITH THE CUTTING ACCESSORY, FOOT, OR LEG. EXCESSIVE PRESSURE MAY FRACTURE THE CUTTING ACCESSORY OR BEND THE ATTACHMENT FOOT OR LEG." THE EVENT DID NOT INVOLVE A PRODUCT PROBLEM INDICATING A NON-CONFORMITY OR UNANTICIPATED HAZARD. NO FURTHER ACTION IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

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

    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.

    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
    92624 2.3MM TAPERED ROUTER DRILLS, BURRS, TREPHINES & ACCESSORIES HBE STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 5407FA2000, S/N:(B)(4)