BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMK-HINGE FIXED TIBIAL INSERT SIZE 4/12MM

    MDR report key: 6463876 · Received April 6, 2017

    Report

    Report Number
    3005180920-2017-00160
    Event Type
    Malfunction
    Date Received
    April 6, 2017
    Date of Event
    March 7, 2017
    Report Date
    April 6, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KRO
    PMA / PMN Number
    K130299
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 15 MAR 2017 AND INCLUDES: THE MISSING SCREW WAS THE POST SCREW, NOT THE SMALLER INSERT SCREW. AS SOON AS THE PACKAGING WAS OPENED WE WERE STANDING DIRECTLY OVER THE TABLE TO EXPLAIN THAT IT MUST BE REMOVED FROM THE POST - IT WAS NOT THERE. WHEN WE OPENED THE NEW INSERT IT WAS IMMEDIATELY APPARENT. IT WAS NOT NOTICED BEFORE THE PACKAGING WAS OPENED. IT WAS NOT EXPECTED THAT IT WOULD BE MISSING. EVEN IF WE HAD NOTICED IT WAS MISSING BEFORE OPENING THE FINAL WRAPPING, I WOULD HAVE OPENED IT TO CHECK INSIDE THE FINAL WRAPPING FOR THE SCREW IN THE EVENT IT HAD SOMEHOW COME OUT OF THE POST BUT WAS STILL IN THE STERILE PACK AND USABLE. WE WERE AND ARE ALWAYS VERY CAREFUL WHEN OPENING IMPLANTS. WE SEARCHED EVERY INCH OF THAT SCRUB TABLE. WE ALWAYS PREPARE A CLEAN REDRAPED CLEAR AREA FOR IMPLANT PREP. BATCH REVIEW PERFORMED ON 17 MARCH 2017. LOT 161842: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04 APRIL 2016. EXPIRATION DATE: 2021-03-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD AND THIS IS THE SECOND SIMILAR EVENT REPORTED ON THE LOT. ON 15 MARCH 2017 THE PACKAGING AND CLEANING MANAGER PERFORMED: WE CHECKED THE TRACEABILITY OF THE LOT OF SCREWS INVOLVED IN THIS COMPLAINT, AND WE ENCOUNTERED NO ANOMALIES OR NUMERICAL DISCREPANCIES THAT MAY SUGGEST A FAILURE TO INSERT THE SCREW IN THE FINAL PACKAGING. THE CHECK WAS MADE ON ALL LOTS THAT SHOWED THE USE OF THIS SCREW. BASED ON THE INFORMATION RECEIVED IT IS NOT POSSIBLE TO DEFINE A CERTAIN ROOT CAUSE AND NO ANOMALY WAS FOUND.

    Description of Event or Problem · 1

    THE INSERT PACKAGE WAS MISSING THE SCREW TO LOCK THE INSERT TO THE HINGE COMPONENT. A 10MM INSERT WAS OPENED AND THE SCREW FROM THAT WAS USED TO COMPLETE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251536 GMK-HINGE FIXED TIBIAL INSERT SIZE 4/12MM FIXED TIBIAL INSERT KRO MEDACTA INTERNATIONAL SA 161842

    Patients

    Seq Age Sex Outcome Treatment
    1 Other