BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIOLUCENT WRIST FIXATOR KIT COMPLETE SYSTEM

    MDR report key: 2660895 · Received July 11, 2012

    Report

    Report Number
    9680825-2012-00023
    Event Type
    Malfunction
    Date Received
    July 11, 2012
    Date of Event
    March 14, 2012
    Report Date
    July 10, 2012
    Manufacturer
    ORTHOFIX SRL
    Product Code
    JDW
    PMA / PMN Number
    K955848
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF HISTORICAL RECORDS: ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON BOTH LOTS BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE LOT V1212033, MANUFACTURED IN 2011, WAS COMPRISED OF 100 DEVICES WHILE THE LOT V1241652, MANUFACTURED IN 2011, WAS COMPRISED OF 150 DEVICES. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX SRL HISTORICAL RECORDS, NO OTHER SIMILAR FAILURES HAVE BEEN REPORTED FROM THESE SPECIFIC DEVICE LOTS. ORTHOFIX SRL HAS REQUESTED TO THE DISTRIBUTOR INVOLVED PATIENT'S DETAILS INCLUDING AN UPDATE ON THE CURRENT HEALTH CONDITION AND COPY OF THE PRE AND POST OPERATIVE X-RAYS AND THE DEVICE AVAILABILITY FOR THE TECHNICAL INVESTIGATION. UNFORTUNATELY, THIS INFORMATION HAS NOT YET MADE AVAILABLE. AS SOON AS FURTHER INFORMATION AND/OR THE RESULTS OF THE TECHNICAL INVESTIGATION WILL BE AVAILABLE, ORTHOFIX SRL WILL PROVIDE YOU WITH A FOLLOW UP REPORT. ORTHOFIX SRL CONTINUES MONITORING THE DEVICES ON THE MARKET.

    Description of Event or Problem · 1

    THE INFORMATION PROVIDED BY THE DISTRIBUTOR INDICATES: AFTER THE OPERATION, THE PATIENT WAS SENT BACK TO THE WARD. BUT THE PIN CLAMP OF THE CODE 99-36501 WAS CRACKED AND SPLITTED FROM THE MAIN PART WITHOUT LOOSENING THE BALL-JOINT. NO ADVERSE EFFECTS OR THE PATIENT AS A REPLACEMENT PART WAS IMMEDIATELY AVAILABLE. THE COMPLAINT REPORT RECEIVED BY THE LOCAL DISTRIBUTOR INDICATES TWO DIFFERENT LOT NUMBERS (V1212033 AND V1241652). IT IS NOT YET CONFIRMED, WHICH IS THE LOT INVOLVED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIOLUCENT WRIST FIXATOR KIT COMPLETE SYSTEM RADIOLUCENT WRIST FIXATOR KIT COMPLETE S JDW ORTHOFIX SRL 99-36501 V1212033 OR V1241652

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK NO INFORMATION HAVE BEEN MADE AVAILABLE.