BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATRIX SIMPLE PERSUADER-LONG

    MDR report key: 3002484 · Received March 13, 2013

    Report

    Report Number
    8030965-2013-10493
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 7, 2012
    Report Date
    February 7, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO 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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE PRODUCT DEVELOPMENT EVALUATION SHOWED THREADED PERSUADER (03.632.008), STANDARD SIMPLE PERSUADER (03.632.009) AND LONG SIMPLE PERSUADER (03.632.079) WERE RETURNED. BOTH STANDARD SIMPLE PERSUADERS AND 1 LONG SIMPLE PERSUADER WERE RETURNED ALSO. ONE OF THE LONG PERSUADERS WAS NOT RETURNED. ONE OF THE THREADED PERSUADERS WAS NOT RETURNED AND ONLY THE REDUCTION TUBE WAS RETURNED FOR THE OTHER. THE PART OF THAT DEVICE THAT WOULD NEED TO BE EVALUATED, REDUCTION INSERT, BASED ON THE REPORTED CONDITION WAS NOT RETURNED FOR EITHER OF THEM. THEREFORE, THE EVALUATION WAS NOT POSSIBLE FOR THE 2 THREADED PERSUADERS AND 1 LONG SIMPLE PERSUADER. OF THE 3 SIMPLE PERSUADERS THAT WERE RETURNED, ALL THREE OF THE DEVICE FUNCTION AS INTENDED. THEY OPEN AND CLOSE EASILY AND RELEASE AND SPRING BACK INTO POSITION AS INTENDED WHEN THE RELEASE BUTTON IS PRESSED. EACH WAS TRIED 10 TIMES AND THEY SPRUNG BACK INTO POSITION WHEN THE RELEASE BUTTON WAS PRESSED. THE RETURNED DEVICES FUNCTION AS INTENDED AND THE COMPLAINT CONDITION COULD NOT BE REPLICATED. IT IS CONCLUDED THAT SINCE THE SIMPLE PERSUADERS THAT WERE RETURNED FUNCTIONED AS INTENDED AND THE COMPLAINT CONDITION COULD NOT BE REPLICATED, THAT THIS COMPLAINT IS INVALID. THE THREADED PERSUADERS AND ONE LONG SIMPLE PERSUADER COULD NOT BE EVALUATED EITHER BECAUSE THEY WERE DISASSEMBLED AND THE NECESSARY PARTS WERE NOT RETURNED OR THE DEVICE ITSELF WAS NOT RETURNED.

    Additional Manufacturer Narrative · 1

    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 POSTERIOR FUSION AT T10-S1, THE BLACK INNER PIECE OF THE MATRIX THREADED PERSUADER BROKE ON BOTH DEVICES WHILE THE SURGEON WAS PERSUADING. ALSO REPORTED, THE MATRIX THREADED PERSUADER, STANDARD AND A SECOND MATRIX THREADED PERSUADER LONG ARE BINDING UP AND STICKING. THE GEARS ON THE PERSUADERS ARE BINDING UP. THE HANDLE OF THE PERSUADERS DOES NOT SPRING BACK SMOOTHLY AS IT SHOULD ONCE SQUEEZED. THE BROKEN PIECE WAS RETRIEVED. THE SURGEON COMPLETED THE PROCEDURE WITH NO FURTHER PROBLEMS, AND NO HARM TO PATIENT. THIS IS REPORT 3 OF 3 FOR THIS EVENT.

    Description of Event or Problem · 1

    THIS IS REPORT 4 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105771 MATRIX SIMPLE PERSUADER-LONG LXH SYNTHES MONUMENT T953783

    Patients

    Seq Age Sex Outcome Treatment
    1