BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATRIX THREADED PERSUADER

    MDR report key: 2945171 · Received February 1, 2013

    Report

    Report Number
    1719045-2013-10035
    Event Type
    Malfunction
    Date Received
    February 1, 2013
    Date of Event
    February 25, 2011
    Report Date
    February 25, 2011
    Manufacturer
    SYNTHES (USA) MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. TWO DEVICES WERE RETURNED WITH THE REDUCTION INSERT BROKEN. NO HANDLES WERE RETURNED, BUT SOME FRAGMENTS FROM THE BROKEN REDUCTION INSERT WERE INCLUDED. THIS COMPLAINT IS INDETERMINED BECAUSE THE DAMAGED PORTIONS OF THE PRODUCTS MAKE PHYSICAL DIMENSIONAL VERIFICATION IMPOSSIBLE. SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO A FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, THE MATRIX THREADED PERSUADER HANDLE BROKE OFF AND THE PIECE WAS RETRIEVED FROM THE PATIENT. THE SURGEON SELECTED A SECOND PERSUADER AND THE HANDLE BROKE OFF AS WELL. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT AND THE SURGEON COMPLETED THE PROCEDURE SUCCESSFULLY. THIS REPORT IS ON THE 1ST PERSUADER. THIS IS 1 OF 2 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44368 MATRIX THREADED PERSUADER LXH SYNTHES (USA) MONUMENT 6390308

    Patients

    Seq Age Sex Outcome Treatment
    1