BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI NUT 11MM WIDTH ACROSS FLATS

    MDR report key: 3032647 · Received April 3, 2013

    Report

    Report Number
    2530088-2013-00520
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 7, 2013
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MNH
    PMA / PMN Number
    K992739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE DEVICE WAS REVIEWED BY MANUFACTURING: THE NUT IS JAMMED ON THE M8 THREAD OF THE SCREW AND CAN NOT BE REMOVED. MINOR DAMAGE ON THE HEXAGONAL SHAPE OF THE NUT. THIS IS NOT MANUFACTURE RELATED. THE DEVICE WENT TO PRODUCT DEVELOPMENT: THE COLLAR WAS RECEIVED FRACTURED IN TWO PIECES. THE DEFORMATION OF THE COLLAR SHOWS PLASTIC DEFORMATION PRIOR TO THE FRACTURE OCCURRING. IT IS POSSIBLE THAT THE ROD WAS NOT FULLY CENTERED BETWEEN THE SCREW AND THE COLLAR WHICH LEAD TO AN OFF-AXIS LOADING. THIS LOADING MAY HAVE CREATED A BENDING LOAD CAUSING THE YIELDING AND FRACTURING THAT OCCURRED. THE ORIENTATION OF THE NUT IS OFF-AXIS WHICH CORRESPONDS TO THE OFF-AXIS LOADING WHICH MAY HAVE LEAD TO THE YIELDING FRACTURE. THE RESULTS OF THIS MANUFACTURING EVALUATION INDICATE EACH PROCESS WAS CARRIED OUT ACCORDING TO THE ENGINEERING SPECIFICATIONS, AND WORK INSTRUCTIONS APPLICABLE TO EACH DEPARTMENT. A PRODUCT DESIGN EVALUATION WAS ALSO CONDUCTED. THIS REVIEW FOCUSED ON THE INTERACTION OF THE COLLAR, AND NUT WITH THE MATING INSTRUMENTS AND THEIR INTERACTION WITH THE SIDE OPENING IMPLANTS. A COMPREHENSIVE REVIEW OF THE DESIGN WAS CONDUCTED BY AN INDEPENDENT INDUSTRY EXPERT. THIS REVIEW DETERMINED THAT THE USS COLLAR COULD BE IMPROVED WITH CHANGES TO THE WAY THE DRAWING WAS SPECIFIED AND TOLERANCES APPLIED. THESE CHANGES HELPED TO MAKE THE PART MORE TIGHTLY CONTROLLED; WHILE KEEPING THE COLLAR FULLY WITHIN THE DESIGN ENVELOPE. THIS REFINED PROCESS ON NEW PRODUCTION EQUIPMENT WILL MITIGATE THE PRODUCT DESIGN AS A ROOT CAUSE FOR FAILURE. SPINE PRODUCT DEVELOPMENT INITIATED A FIELD ACTION PROCESS WITH THE EXPRESS PURPOSE OF EVALUATING WHETHER OR NOT A SPECIFIC FIELD ACTION WOULD BE REQUIRED. THIS PROCESS INVOLVES ALL ASPECTS OF THE BUSINESS FROM CORPORATE QUALITY, COMPLAINT HANDLING, REGULATORY AFFAIRS, PRODUCT DEVELOPMENT, MATERIAL DEVELOPMENT, MANUFACTURING AND EXECUTIVE MANAGEMENT. AFTER A THOROUGH REVIEW OF ALL AVAILABLE DATA ON OPEN COMPLAINTS IT HAS BEEN RECOMMENDED THAT NO FORMAL FIELD ACTION IS REQUIRED AT THIS TIME. IT IS NOT CLEAR EXACTLY WHAT LOADING SCENARIO WAS APPLIED, ROD NOT BEING CENTERED, WHAT TORQUE WAS APPLIED OFF-AXIS.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. DHR REVIEW FOUND NO RELEVANT ISSUES THAT WOULD RESULT IN THIS PRODUCT COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2013, SURGEON WAS USING THE USS SYSTEM TO FOR AN IDIOPATHIC SPINE DEFORMITY SURGERY AT T3-L2. , AS THE SURGEON WAS PUTTING THE NUT ON, THE COLLAR BROKE AND THE NUT BECAME JAMMED ONTO THE TOP OF THE SCREW AND WOULD NOT COME OFF. THEREFORE, THE SURGEON REMOVED THE COLLAR, NUT AND SCREW AND REPLACED ALL THREE PIECES WITH NEW ONES. SURGEON WAS PROLONGED APPROXIMATELY 10 MINUTES. NO ADVERSE EFFECT TO THE PATIENT. THIS IS 2 OF 3 REPORTS FOR THIS EVENT.

    Description of Event or Problem · 1

    THIS IS 1 OF 3 REPORTS FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135956 TI NUT 11MM WIDTH ACROSS FLATS MNH SYNTHES BRANDYWINE 7198174

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR