BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI COLLAR WITH GROOVES

    MDR report key: 3063764 · Received April 17, 2013

    Report

    Report Number
    2530088-2013-10432
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    October 13, 2011
    Report Date
    October 13, 2011
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MNH
    PMA / PMN Number
    K992739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    NURSE

    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 DEVICE WAS RECEIVED AND A COMPLETE MANUFACTURING EVALUATION WAS CONDUCTED. THE RESULTS OF THE MANUFACTURING EVALUATION INDICATED EACH PROCESS WAS CARRIED OUT ACCORDING TO THE ENGINEERING SPECIFICATIONS AND WORK INSTRUCTIONS APPLICABLE TO EACH DEPARTMENT. EQUIVALENT UNIVERSAL SPINE SYSTEM (USS) COLLARS FROM SYNTHES (B)(4) WERE MADE AVAILABLE FOR EVALUATION IN ORDER TO RULE OUT MANUFACTURING AS BEING PART OF THE ROOT CAUSE. 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. MECHANICAL TESTING HAS SHOWN THAT THIS COLLAR IS SUSCEPTIBLE TO FRACTURE WITHIN THE ROD SLOT AT THE ROOT OF THE GROOVES. EACH GROOVE ACTS AS A STRESS RISER WITHIN THE PART AND IS A LIKELY PLACE FROM WHICH A CRACK WILL PROPAGATE. TO MITIGATE THIS AS A POTENTIAL ROOT CAUSE FOR FAILURE, THE USS COLLAR WILL BE RE-RELEASED TO THE U.S. MARKET. TESTING HAS SHOWN THAT THIS COLLAR WILL NOT CRACK UNDER HIGH TORSIONAL LOADS. THE OVERALL ANALYSIS OF THE INVESTIGATION INDICATED THAT NO ROOT CAUSE COULD BE FOUND FOR THE REPORTED COMPLAINT. SEVERAL PROCESS IMPROVEMENTS HAVE BEEN IDENTIFIED AND IMPLEMENTED. (B)(4).

    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. ADDITIONAL NARRATIVE: THE MANUFACTURING EVALUATION REVEALED THE RETURNED DEVICE WAS BROKEN IN HALF AT THE GROOVES. DUE TO THE RETURNED CONDITION OF THE COMPONENT ONLY A CALCULATED WALL THICKNESS WAS INSPECTED. NO OTHER RELEVANT FEATURES COULD BE VERIFIED; THEREFORE, THE EVALUATION DETERMINED THE COMPLAINT TO BE INDETERMINATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE WHILE THE SURGEON WAS DOING THE FINAL TIGHTENING FOR A CONSTRUCT L1-L5 WHEN A TI COLLAR WITH GROOVE BROKE IN HALF. THE SURGEON REMOVED THE COLLAR, SELECTED ANOTHER AND COMPLETED THE PROCEDURE. NO PIECES OF THE COLLAR WERE LEFT IN THE PATIENT.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR THIS COMPLAINT (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164832 TI COLLAR WITH GROOVES MNH SYNTHES BRANDYWINE 6759024

    Patients

    Seq Age Sex Outcome Treatment
    1