BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AP REF - FEMORAL CUTTING GUIDE 4/1- SIZE 6

    MDR report key: 6260052 · Received January 18, 2017

    Report

    Report Number
    3005180920-2016-00742
    Event Type
    Malfunction
    Date Received
    January 18, 2017
    Date of Event
    December 19, 2016
    Report Date
    January 18, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 16 JANUARY 2017. LOT 1112275: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29 NOVEMBER 2012. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, THIS IS THE SECOND SIMILAR EVENT REPORTED ON ITEMS OF THE SAME LOT. ON 18 JANUARY 2017 THE R&D PROJECT MANAGER PERFORMED A PRELIMINARY INVESTIGATION OF THIS CASE AND COMMENTED AS FOLLOWS: THE BREAKING OF THE CUTTING GUIDE COULD HAVE BEEN CAUSED DUE EXCESSIVE FORCE DURING PLACING THE GUIDE INTO CONTACT WITH THE DISTAL FEMUR RESECTION. DURING THIS PHASE, IN PARTICULAR USING THE CUTTING GUIDE IN COMBINATION WITH THE POSTERIOR PEGS, THE FRONTAL IMPACTION CAN CAUSE THE BREAKAGE OF THE ANTERIOR CHAMFER LATERAL RESISTANT SECTIONS. IN THIS PARTICULAR CASE THE GUIDE WAS PROBABLY ALREADY BENDED BEFORE THE SURGERY OR IT COULD BE DEFORMED DURING THE FIRST PLACING ON THE DISTAL FEMUR (THE FACT IS THAT THE CUTTING SLOT WAS TOO NARROW AND THE BLADE DIDN'T FIT IN THE SLOT) PROBABLY DUE TO A PRESENCE OF INITIAL FRACTURE ON THE LATERAL SECTIONS. ONCE THE SURGEONS TRIED TO REMOVE THE GUIDE THE PIECE BROKE IN HALF. IN THE SURGICAL TECHNIQUE, DEDICATE CAUTIONS ARE PRESENT ON HOW TO PLACE THE 4 IN 1 CUTTING GUIDE TO PREVENT DAMAGE DURING IMPACTIONS. NOT YET RECEIVED.

    Description of Event or Problem · 1

    WHEN THE SURGEON WAS PLACING THE SAW BLADE INTO THE GUIDE, IT WOULD NOT FIT INTO THE BLOCK. HE PULLED THE BLOCK OFF THE FEMUR. THE BLOCK BROKE IN HALF. NO FRAGMENTS FELL INTO THE PATIENT. ANOTHER CUTTING GUIDE WAS USED TO COMPLETE THE SURGERY. THE SURGERY WAS DELAYED APPROXIMATELY 30 MINUTES. THE SURGERY WAS COMPLETED SUCCESSFULLY. INSTRUMENTATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43214 AP REF - FEMORAL CUTTING GUIDE 4/1- SIZE 6 SURGICAL INSTRUMENT FOR KNEE LXH MEDACTA INTERNATIONAL SA 1112275

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other