BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIOLUCENT WRIST FIXATOR KIT COMPLETE SYSTEM

    MDR report key: 2663008 · Received July 17, 2012

    Report

    Report Number
    9680825-2012-00027
    Event Type
    Malfunction
    Date Received
    July 17, 2012
    Date of Event
    June 5, 2012
    Report Date
    July 13, 2012
    Manufacturer
    ORTHOFIX SRL
    Product Code
    JDW
    PMA / PMN Number
    K955848
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 THIS SPECIFIC LOT BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2012, WAS COMPRISED OF (B)(4) 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 THIS SPECIFIC DEVICE LOT. THE RETURNED DEVICE, RECEIVED ON (B)(4) 2012, IS CURRENTLY UNDER TECHNICAL INVESTIGATION. A CLINICAL EVALUATION OF THE CASE WAS NOT PERFORMED AS NO INFORMATION ABOUT PATIENT CONDITIONS, MEDICAL PROCEDURE, DIAGNOSIS AND X-RAYS HAVE BEEN MADE AVAILABLE. AS SOON AS FURTHER INFORMATION ON THE EVENT AND/OR THE RESULTS OF THE TECHNICAL INVESTIGATION WILL BECOME AVAILABLE, ORTHOFIX SRL WILL FINALIZE THE INVESTIGATION AND 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 HOSPITAL INDICATES: THE DEVICE, CODE 99-36501, BROKE IN CORRESPONDENCE TO THE BALL-JOINT. NO ADVERSE EFFECTS FOR THE PATIENT. (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 V1247953

    Patients

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