BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL IMPLANT, SMALL, RIGHT

    MDR report key: 5378379 · Received January 19, 2016

    Report

    Report Number
    3004608878-2016-00020
    Event Type
    Malfunction
    Date Received
    January 19, 2016
    Date of Event
    October 20, 2015
    Report Date
    October 21, 2015
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    JWJ
    PMA / PMN Number
    K030037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA COMPLETED ITS INTERNAL INVESTIGATION 21DEC2015. THE INVESTIGATION INCLUDED: METHOD: - REVIEW OF DEVICE HISTORY RECORDS. - REVIEW OF COMPLAINT MANAGEMENT DATABASE FOR SIMILAR COMPLAINTS. RESULTS: THERE WERE NO MATERIAL NON-CONFORMANCES OR VARIANCES ASSOCIATED WITH THIS LOT OF IMPLANTS. A QUERY IN THE COMPLAINT DATABASE DID NOT IDENTIFY OTHER CUSTOMER COMPLAINTS ASSOCIATED WITH A REPORTED DISTRIBUTION OF EXPIRED UNIVERSAL2 TOTAL WRIST IMPLANTS. THE QUERY WAS LIMITED TO THE TIME FRAME OF 2012 TO 2015 YEAR TO DATE. THE FIVE COMPLAINTS ASSOCIATED WITH THE DISTRIBUTION OF EXPIRED IMPLANTS ARE THE ONLY ONES ASSOCIATED WITH THE UNIVERSAL2 TOTAL WRIST SYSTEM. A REVIEW OF SALES FIGURES DETERMINED THAT (B)(4) INDIVIDUAL UNIVERSAL2 IMPLANTS WERE SOLD WORLDWIDE FROM JANUARY 2012 TO OCTOBER 1, 2015. THE SHIPMENT OF FIVE EXPIRED IMPLANTS RESULTS IN A FAILURE RATE OF (B)(4). CONCLUSION: BASED ON THE INFORMATION THAT WAS PROVIDED FROM THE COMPLAINANT, INTEGRA WAS ABLE TO CONFIRM THAT EXPIRED PRODUCT WAS SHIPPED FROM INTEGRA (B)(4) TO A HOSPITAL. AN INVESTIGATION CONDUCTED BY INTEGRA (B)(4) QUALITY ASSURANCE AND REGULATORY AFFAIRS IDENTIFIED THE ROOT CAUSE AS A BREAKDOWN IN THE INSPECTION PROCESS FOR THE RELEASE OF PRODUCT TO THE FIELD. INTEGRA (B)(4) INITIATED A CAPA TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    THIS IS REPORT 5 OF 5 FOR THE SAME PRODUCT ISSUE. MFR. NUMBERS FOR THE 5 REPORTS: 3004608878-2015-00289; 3004608878-2016-00017; 3004608878-2016-00018; 3004608878-2016-00019; 3004608878-2016-00020. IT WAS REPORTED THAT AFTER A PROCEDURE WHERE EXPIRED PRODUCT WAS IMPLANTED, THE SALES REPRESENTATIVE WENT THROUGH THE REMAINING STOCK AND FOUND A NUMBER OF OTHER IMPLANTS WHICH WERE ALSO EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35599 RADIAL IMPLANT, SMALL, RIGHT UNI2 TOTAL WRIST IMPLANT SYSTEM JWJ INTEGRA LIFESCIENCES CORPORATION OH/USA 087628

    Patients

    Seq Age Sex Outcome Treatment
    1