BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATRIX THREADED PERSUADER- STANDARD

    MDR report key: 2830979 · Received November 14, 2012

    Report

    Report Number
    1719045-2012-01145
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 17, 2012
    Report Date
    October 17, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    NKB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. AS NOTED IN PRIOR COMPLAINTS, IMPROPER ASSEMBLY OF THE INSTRUMENT, NOT FULLY SEATING THE INSERT, BY THE OR STAFF LIKELY CAUSED THE REDUCTION INSERT TO SEE EXCESSIVE LOADING IN THE REGION OF FAILURE DURING REDUCTION. RATHER THAN HAVING THE AXIAL LOADS REACTED BY THE THRUST SURFACE ON THE UNDERSIDE OF THE HEAD, THE FINGERS INSTEAD CONTACT THE RETENTION RIB AND ARE SQUEEZED INTO THE INNER TUBE AS REDUCTION LOADS ARE APPLIED POTENTIALLY CAUSING THEM TO BREAK. THE BREAKAGE NOTED ON THE RETURNED PART IS CONSISTENT WITH THAT EXPECTED IF THE DEVICE IS ASSEMBLED INCORRECTLY AS NOTED. THE DESIGN RISK ASSESSMENT WAS REVIEWED AND WAS FOUND TO BE ADEQUATE FOR THE INTENDED USE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE PRODUCT CONFORMED TO ALL REQUIREMENTS. PLACEHOLDER.

    Description of Event or Problem · 1

    DURING A L4-L5 PLIF PROCEDURE, THE THREADED INTERNAL BUSHING/PLASTIC THREADS OF THE MATRIX THREADED PERSUADER BROKE DURING THE REDUCTION. THE BROKEN PARTS WERE CONTAINED IN THE PERSUADER. THE SURGEON DID NOT USE AN ALTERNATE PERSUADER. THE SURGEON ACHIEVED REDUCTION WITH DISTRACTION. THERE WAS A TWENTY MINUTE DELAY IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED. THERE ARE TWO PARTS, LEFT SIDE AND RIGHT SIDE, THEY COME AS A SINGLE SET YOU USE BOTH TOGETHER. BOTH DEVICES BROKE IN THIS PROCEDURE. THIS IS 2 OF 2 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MATRIX THREADED PERSUADER- STANDARD MATRIX THREADED PERSUADER NKB SYNTHES MONUMENT 6390270

    Patients

    Seq Age Sex Outcome Treatment
    1 MATRIX THREADED PERSUADER