BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JTS DRIVE UNIT

    MDR report key: 6224639 · Received January 5, 2017

    Report

    Report Number
    3004105610-2016-00148
    Event Type
    Injury
    Date Received
    January 5, 2017
    Date of Event
    June 27, 2014
    Report Date
    June 27, 2014
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD
    Product Code
    KRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE JTS DRIVE UNITS ARE MANUFACTURED BY AN APPROVED STANMORE IMPLANTS WORLDWIDE (SIW) SUPPLIER. AN EVALUATION OF THE RETURNED JTS DRIVE UNIT DETERMINED THAT THE DRIVE UNIT WAS INCORRECTLY MANUFACTURED IN THAT THE WIRES OF THE FILTER "U" AND "V" CONNECTED TO THE COIL WERE SWITCHED. THIS RESULTED IN THE JTS DRIVE UNIT ROTATING IN THE WRONG DIRECTION. THE SUPPLIER WAS MADE AWARE OF THIS MANUFACTURING ISSUE. THE SUPPLIER SUBSEQUENTLY ISSUED SCAR ((B)(4)) AND CAPA (B)(4). SUPPLIER CAPA, (B)(4), DETAILS UPDATED TEST AND RELEASE INSTRUCTIONS AND FORMS FOR CLARIFIED JTS DRIVE UNIT RELEASE PROCEDURES. A REVIEW OF PREVIOUS COMPLAINTS SHOWS THAT NO COMPLAINTS ON THIS ISSUE HAVE BEEN RAISED FOLLOWING IMPLEMENTATION OF THIS CAPA. AS AN ADDITIONAL SAFEGUARD SIW IS ALSO IN THE PROCESS OF INTRODUCING INTERNAL PROCEDURES TO INSPECT JTS DRIVE UNITS PRIOR TO DISPATCH TO USERS. NO FURTHER INVESTIGATION IS POSSIBLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED. SIW WILL CONTINUE TO MONITOR FOR TRENDS. THIS COMPLAINT FILE WAS REVIEWED AS PART OF SIW COMPLAINT FILE REMEDIATION PROGRAMME AND IT HAS BEEN DETERMINED THAT AN MDR SHOULD BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SURGEON THAT THE JTS DRIVE UNIT USED TO EXTEND THE NON-INVASIVE EXTENDIBLE PROSTHESIS IS FAULTY AND NOT WORKING AS INTENDED. IT IS THOUGHT THAT IT IS SHORTENING THE PATIENT'S LEG RATHER THAN LENGTHENING IT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8189 JTS DRIVE UNIT LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE LTD 907-115 907-115

    Patients

    Seq Age Sex Outcome Treatment
    1 Other