BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADJUSTMENT BLOCK - STANDARD

    MDR report key: 3123808 · Received May 22, 2013

    Report

    Report Number
    0002249697-2013-01743
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 1, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS REPORTED FOR THE REPORTED MANUFACTURING LOT THE INVESTIGATION DETERMINED THE LIKELY ROOT CAUSE OF THE EVENT TO BE USER ERROR AND/OR CONFUSION AS THE DEVICE IS DIMENSIONALLY WITHIN SPECIFICATION FOR THE 8MM SETTING. THERE IS NO INDICATION AT THIS TIME THAT THE DESIGN, MATERIALS, OR MANUFACTURING OF THE SUBJECT DEVICE CONTRIBUTED TO THE EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    THE FEMORAL ADJUSTMENT BLOCK 6451-1-600 WAS SET AT 8MM RESECTION AS PER SURGICAL TECHNIQUE. WHEN MEASURED POST RESECTION THE CUT WAS ACTUALLY 11+ MM THICK.

    Description of Event or Problem · 1

    THE FEMORAL ADJUSTMENT BLOCK 6451-1-600 WAS SET AT 8MM RESECTION AS PER SURGICAL TECHNIQUE. WHEN MEASURED POST RESECTION THE CUT WAS ACTUALLY 11+ MM THICK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225790 ADJUSTMENT BLOCK - STANDARD INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH P4T11

    Patients

    Seq Age Sex Outcome Treatment
    1 Other