BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THREADED PERSUADER-STANDARD

    MDR report key: 4490292 · Received February 6, 2015

    Report

    Report Number
    3003875359-2015-10075
    Event Type
    Malfunction
    Date Received
    February 6, 2015
    Date of Event
    January 16, 2015
    Report Date
    January 22, 2015
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. IMPLANT AND EXPLANT DATES: DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. INITIAL REPORTER TELEPHONE NUMBER: (B)(4). A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED. THERE WERE NO ANOMALIES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    A PRODUCT DEVELOPMENT EVALUATION WAS PERFORMED FOR THE SUBJECT DEVICE. THE THREADED PERSUADER (03.632.408 LOT 7833867) WAS RECEIVED UNDER THE COMPLAINT CONDITION ¿BROKEN¿. THE REDUCTION INSERTS WERE DAMAGED. THERE WERE TWO BROKEN THREADED TABS. THE THREADED PERSUADER IS UTILIZED IN THE MATRIX SPINE SYSTEM AS A ROD REDUCTION DEVICE; SPECIFICALLY UTILIZED TO SEAT RODS AND SECURE LOCKING CAPS THE TECHNIQUE GUIDE WAS REVIEWED. RELEVANT DRAWINGS FOR THE INSTRUMENT FROM THE TIME OF MANUFACTURING (JUNE 28, 2012) WERE REVIEWED: TOP-LEVEL AND REDUCTION INSERT. ALL DRAWINGS CALL OUT THE APPROPRIATE DIMENSIONS, MATERIAL AND FINISHING PROCESSES FOR A SUCCESSFUL DESIGN. THE FOLLOWING CHANGES WERE IMPLEMENTED: REDUCTION INSERT MATERIAL CHANGED TO IMPLANT GRADE PEEK TO MITIGATE RISKS ASSOCIATED WITH PART BREAKAGE, THE REDUCTION INSERT THREAD PATTERN HAS MODIFIED FROM A STANDARD 60 DEGREE TO A 10 DEGREE, ADDITIONALLY AN ALIGNMENT PIN WAS REMOVED AND THE BLOCKING FEATURE WAS EXTENDED. THESE CHANGES WERE IMPLEMENTED IN ORDER TO REDUCE THE NECESSARY TORQUE INPUT, AND THEREFORE REDUCE THE LIKELIHOOD OF EXCESSIVE TORQUE BEING APPLIED WHICH CAN LEAD TO INSTRUMENT FAILURE. WHEN ASSEMBLING THE PERSUADER CONSTRUCT, THE INNER SHAFT IS INSERTED INTO THE OUTER SHAFT. THEN THE REDUCTION INSERT IS INSERTED INTO THE PROXIMAL END OF THE OUTER SHAFT AND SNAPPED INTO POSITION, AN AUDIBLE CLICK WILL BE HEARD; AT THE POINT THE INNER TUBE CAN BE THREADED INTO THE REDUCTION INSERT. THE FAILURE MODE OF DAMAGED/BROKEN TABS ON THE REDUCTION INSERT HAS BEEN ASSOCIATED WITH IMPROPER ASSEMBLY OF THE INSTRUMENT, CAUSING EXCESSIVE LOADING ON THE INSERT TABS DURING REDUCTION. THE SYSTEM TECHNIQUE GUIDE WAS UPDATED TO INCLUDE ASSEMBLY INSTRUCTIONS. THE COMPLAINT CONDITION WAS CONFIRMED, HOWEVER, A DEFINITIVE ROOT CAUSE IS UNABLE TO BE DETERMINED. THE FAILURE MODE IS CONSISTENT WITH ATTEMPTED REDUCTION WITH AN IMPROPERLY ASSEMBLED INSTRUMENT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM (B)(6) REPORTED THE FOLLOWING EVENT. THE PLASTIC PART OF THE PERSUADER WAS FOUND BENT, CRACKED, AND BREAKING AT THE THREADED SIDE, MAKING IT DIFFICULT TO ASSEMBLE OR USE THE INSTRUMENT. DURING A PROCEDURE, THE SURGEON HAD PERFORMED REDUCTION USING TWO STANDARD THREADED PERSUADERS. AFTER THE INSTRUMENT WAS REMOVED AND THE REDUCTION WAS COMPLETE, THE SCRUB NURSE WAS ATTEMPTING TO DISASSEMBLE INSTRUMENT AND FOUND IT VERY DIFFICULT TO DO SO. ONCE UNASSEMBLED, IT WAS NOTED THAT THE TABS WERE CRACKED AND BENT. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86734 THREADED PERSUADER-STANDARD MISC ORTHO SURGICAL INSTRUMENT LXH SYNTHES HAGENDORF 7833867

    Patients

    Seq Age Sex Outcome Treatment
    1