BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI 12-POINT NUT-11MM

    MDR report key: 3832765 · Received May 27, 2014

    Report

    Report Number
    2520274-2014-11621
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 7, 2014
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    PK082572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL COMMON DEVICE NAMES: MNI MNH KWP KWQ. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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

    REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A PRODUCT DEVELOPMENT EVALUATION WAS COMPLETED: DRAWINGS FOR THE DUAL-OPENING, TI COLLAR AND THE TI 12-POINT NUT WERE REVIEWED. THESE DRAWINGS WERE FOUND SUITABLE TO DETERMINE THE INTENDED DEVICE DESIGN, APPLICATION AND DIMENSIONAL CONFORMITY. THE SCREW, COLLAR AND NUT WERE FOUND TO HAVE MET THE DRAWING SPECIFICATIONS. CAREFUL EXAMINATION OF THE THREADS UNDER MAGNIFICATION CLEARLY SHOW DEFORMED THREADS AND REMOVED ANODIZATION ON THE FIRST 3 THREADS OF THE SCREW TOP AND THE BOTTOM THREE THREADS OF BOTH NUTS. IT IS LIKELY THAT WHEN ATTEMPTING TO SECURE THE FIRST NUT ONTO THE DUAL-OPENING SCREW, IT WAS NOT INITIALLY SEATED LEVEL ON THE SCREW TOP. AS THE NUT WAS TIGHTENED, IT BECAME CROSS-THREADED AND DAMAGED THE SCREW THREADS IN THE PROCESS. WHEN A SECOND NUT WAS ATTEMPTED, IT WAS NOT ABLE TO BE INSERTED PROPERLY AS THE SCREW¿S DAMAGED THREADS IMPEDED THE PROGRESS. IT APPEARS THAT THE SCREW/COLLAR/NUT ASSEMBLY ISSUES LIE WITH THE SCREW AND NUT¿S BECOMING CROSS THREADED. THE COLLAR APPEARS TO BE IN GOOD WORKING CONDITION, AND DID NOT CAUSE THE COMPLAINT CONDITION. AFTER REVIEWING THE RELATED PRODUCT DRAWINGS, COMPLAINT HISTORY AND RISK ANALYSIS, THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. THE COMPLAINT CONDITIONS OF CROSS THREADED AND DOES NOT FIT WITH OTHER PARTS RESULT FROM A NUT BEING CROSS THREADED ONTO A SCREW AND, IN THE PROCESS, STRIPPING BOTH THE THREADS ON THE NUT AND THE SCREW. AS A RESULT THE ASSEMBLY COULD NOT BE COMPLETED. A SECOND NUT WAS ATTEMPTED, HOWEVER IT WAS NOT ABLE TO BE SEATED PROPERLY AS THE SCREW¿S THREADS WERE TOO DAMAGED. ADDITIONALLY THE COLLAR USED IN THE ASSEMBLY WAS RETURNED; THE COLLAR DOES NOT SHOW ANY SIGNS OF DEFECT. THE COMPLAINT CONDITIONS ARE A RESULT OF A USE ERROR AND NOT A PRODUCT DESIGN ISSUE; AS SUCH THE DEVICES ARE DETERMINED TO BE SUITABLE FOR ITS INTENDED USE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN L3-ILIUM POSTERIOR SPINAL FUSION SURGERY USING USS DUAL OPENING TITANIUM THE LEFT ILIAC SCREW WAS DISCOVERED TO BE STRIPPED. AT THE END OF THE PROCEDURE, WHEN THE SURGEON WAS ATTEMPTING TO CONNECT THE LEFT ILIAC 8.0 X 80MM SCREW TO THE ROD, THE NUT CROSS-THREADED ON THE TOP OF THE LEFT ILIAC SCREW. THE SURGEON REMOVED THE NUT AND TRIED A NEW ONE, BUT THE THREADS ON THE TOP OF THE SCREW WERE STRIPPED. THE SURGEON REMOVED THE NUT, THE COLLAR, AND THE LEFT ILIAC SCREW. HE REPLACED THE SCREW WITH A 9.0 X 80MM SCREW AND USED A NEW NUT AND COLLAR, WHEN CONNECTING THE NEW NUT TO THE NEW SCREW, THE NUT THREADED ON PROPERLY. THE RODS THAT WERE PLACED IN THE PATIENT WERE CUT IN HALF AND USED ON EACH SIDE. THE SURGEON COMPLETED THE PROCEDURE SUCCESSFUL. THERE WAS NO PATIENT HARM. THERE WAS A 10 MINUTE TIME DELAY. THIS REPORT IS FOR THE SECOND OF THE TWO NUTS. THIS IS REPORT 3 OF 5 FOR (B)(4).

    Description of Event or Problem · 1

    THIS IS REPORT 3 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310762 TI 12-POINT NUT-11MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB SYNTHES BRANDYWINE 7580130

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR