BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CMF CUSTOMIZED IMPLANT KIT LARGE

    MDR report key: 2992366 · Received March 7, 2013

    Report

    Report Number
    0002249697-2013-00929
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 12, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KKY
    PMA / PMN Number
    K103010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THE REPORTED DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE COMPLAINT HISTORY REVIEW INDICATED THAT THERE WERE NO SIMILAR EVENTS FOR THE REPORTED LOT. THE EVENT WAS CONFIRMED. ROOT CAUSE WAS DETERMINED TO BE AN INTERNAL PROCESSING ERROR.

    Description of Event or Problem · 1

    IN (B)(4) 2012, CMF CUSTOMIZED IMPLANT, LOT K08258LO11APR (PART NUMBER (B)(4)) WAS MANUFACTURED AND SHIPPED TO THE CUSTOMER. ON (B)(6) 2013, CMF SALES REPRESENTATIVE, (B)(6), NOTIFIED THE STRYKER CMF CUSTOMIZED IMPLANTS TEAM THAT THIS KIT WAS NOT IMPLANTED YET, AND THE STERILITY EXPIRATION DATE PAST. THEREFORE THE CUSTOMER REQUESTED THAT CASE (B)(4) BE REMADE. THE KIT WAS REMADE UNDER LOT ID K08258D IN (B)(4) 2013, AND SHIPPED TO THE CUSTOMER ON (B)(4) 2013. ON (B)(6) 2013 IT WAS REPORTED BY CMF SALES REPRESENTATIVE, (B)(6), TO CMF MARKETING ASSOCIATE, (B)(4), THAT THE INCORRECT INFORMATION WAS RELAYED TO THE DESIGN AND MANUFACTURING TEAM IN (B)(4), AND THEREFORE, THE INCORRECT KIT WAS REMADE. THE PATIENT WAS IN THE OPERATING ROOM WHEN THE DISCREPANCY WAS DISCOVERED, AND THE CASE WAS COMPLETED WITH "LIQUID PMMA" INSTEAD OF THE CMF CUSTOMIZED IMPLANT.

    Description of Event or Problem · 1

    IN (B)(6) 2012 (B)(4) CUSTOMIZED IMPLANT LOT K08258LO11APR (PART NUMBER 5444-0-300) WAS MANUFACTURED AND SHIPPED TO THE CUSTOMER. ON (B)(6) 2013, (B)(4) SALES REPRESENTATIVE, (B)(6), NOTIFIED THE STRYKER (B)(4) CUSTOMIZED IMPLANTS TEAM THAT THIS KIT WAS NOT IMPLANTED YET, AND THE STERILITY EXPIRATION DATE PAST. THEREFORE THE CUSTOMER REQUESTED THAT CASE (B)(4) BE REMADE. THE KIT WAS REMADE UNDER LOT ID K08258D IN (B)(6) 2013, AND SHIPPED TO THE CUSTOMER ON (B)(4) 2013. ON (B)(6) 2013 IT WAS REPORTED BY (B)(4) SALES REPRESENTATIVE, (B)(6), TO (B)(4) MARKETING ASSOCIATE, (B)(4), THAT THE INCORRECT INFORMATION WAS RELAYED TO THE DESIGN AND MANUFACTURING TEAM IN (B)(4), AND THEREFORE THE INCORRECT KIT WAS REMADE. THE PATIENT WAS IN THE OPERATING ROOM WHEN THE DISCREPANCY WAS DISCOVERED, AND THE CASE WAS COMPLETED WITH "(B)(4)" INSTEAD OF THE (B)(4) CUSTOMIZED IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98229 CMF CUSTOMIZED IMPLANT KIT LARGE IMPLANT KKY STRYKER ORTHOPAEDICS-MAHWAH K08258D

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other