BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WIRE TENSIONER

    MDR report key: 2434487 · Received January 5, 2012

    Report

    Report Number
    9680825-2012-00002
    Event Type
    Malfunction
    Date Received
    January 5, 2012
    Date of Event
    November 29, 2011
    Report Date
    January 5, 2012
    Manufacturer
    ORTHOFIX SRL
    Product Code
    JEC
    PMA / PMN Number
    K944092
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A TECHNICIAN EVALUATION OF THE PRODUCT WAS NOT PERFORMED AS THE PRODUCT IS CURRENTLY AT THE DISTRIBUTOR LOCATION. A CLINICAL EVALUATION OF THE X-RAYS OF THE CASE WAS NOT PERFORMED, AS THE X-RAYS HAVE NOT BEEN MADE AVAILABLE. ORTHOFIX SRL HAS REQUESTED THE DEVICE RETURN FOR THE FAILURE INVESTIGATION AND OTHER INFORMATION SUCH AS PATIENT'S INFO AND DIAGNOSIS, PROPOSED TREATMENT AND TYPE OF APPLICATION. ACCORDING TO ORTHOFIX SRL HYSTERICAL DATA, THIS IS THE FIRST EVENT REPORTED. NO OTHER SIMILAR CASE HAS EVER BEEN NOTIFIED SINCE 2003. AS SOON AS THE DEVICE USED WILL BE RECEIVED, ORTHOFIX SRL WILL PROMPTLY PROCEED WITH THE TECHNICAL ANALYSIS. ORTHOFIX SRL CONTINUES MONITORING THE PRODUCTS ON THE MARKET.

    Description of Event or Problem · 1

    THE EVENT DESCRIPTION PROVIDED BY THE DISTRIBUTOR STATED AS FOLLOWS: "TENSIONER WAS BREAKING WIRES WHILE TENSIONING. PATIENT HAD LONGER TIME IN OPERATING THEATRE SINCE SURGEON WAS WAITING REPLACEMENT (THIS WAS DONE WITHIN 45 MINUTES). THERE IS NO PROBLEM WITH THE PATIENT CONDITION SINCE THE PROCEDURE WAS COMPLETED AFTER REPLACEMENT OF THE WIRE TENSIONER." NO OTHER INFORMATION ON PATIENT HAVE BEEN MADE AVAILABLE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WIRE TENSIONER WIRE TENSIONER JEC ORTHOFIX SRL 18001 UNKNOWN

    Patients

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