BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOUR UNI TIBIAL CUT BLK RT

    MDR report key: 3792507 · Received May 6, 2014

    Report

    Report Number
    1020279-2014-00299
    Event Type
    Injury
    Date Received
    May 6, 2014
    Date of Event
    April 17, 2014
    Report Date
    April 17, 2014
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HSX
    PMA / PMN Number
    K113038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASSOCIATED DEVICES WERE RETURNED AND EVALUATED. A FUNCTIONAL ASSESSMENT OF THE DEVICES NOTED THAT THERE WAS A TIGHT FIT BETWEEN THE ALIGNMENT ROD AND TUBE, BUT NO ISSUES WERE NOTED BETWEEN THE COMPLAINED FEATURES OF THE ROD AND CUTTING BLOCK. SUBSEQUENTLY, A DIMENSIONAL INSPECTION WAS PERFORMED ON APPLICABLE FEATURES OF CURRENT INVENTORY. ALL CURRENT INVENTORIES CHECKED WERE FOUND TO BE WITHIN DESIGN SPECIFICATIONS. A REVIEW OF MANUFACTURING RECORDS OF THE COMPLAINT DEVICES DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. AT THIS TIME, WE HAVE NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE OR STAFF EXPERIENCED DIFFICULTIES WITH THE ASSEMBLY OF MATING INSTRUMENTS. SURGERY TIME WAS EXTENDED BEYOND 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272090 JOUR UNI TIBIAL CUT BLK RT ORTHOPAEDIC SURGICAL INSTRUMENTATION HSX SMITH & NEPHEW, INC. 08GM11572

    Patients

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