BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI COLLAR WITH GROOVES

    MDR report key: 3071188 · Received April 22, 2013

    Report

    Report Number
    2530088-2013-10339
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    May 22, 2012
    Report Date
    May 22, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MNI
    PMA / PMN Number
    K091689
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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 PRODUCT CODE FOR THIS REPORT INCLUDES: MNI. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE COLLAR IS ELONGATED, ONE SIDE IS BROKEN AT L2 FEATURE WHERE THE GROOVES ARE AND THE OTHER SIDE THERE IS DAMAGE ON TOP OF THE GROOVES. THIS DAMAGE IS NOT MANUFACTURE RELATED. BECAUSE OF THE PRODUCT RETURN CONDITION, ONLY A CALCULATED WALL THICKNESS WAS MEASURED, AND IS WITHIN TOLERANCE, OTHER RELEVANT FEATURES CAN NOT BE VERIFIED; THEREFORE, THIS COMPLAINT IS INDETERMINATE. EQUIVALENT UNIVERSAL SPINE SYSTEM (USS) COLLARS FROM SYNTHES (B)(4) OPERATIONS 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.

    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 INFORMATION: THIS REPORT WHICH IS REPORT 1 OF 4 FOR COMPLAINT (B)(4) IS FOR THE THREE TI COLLARS WITH GROOVES AND ALL THREE COLLARS HAVE THE SAME LOT NUMBER. THE PRODUCT DEVELOPMENT EVENT EVALUATION REPORTED THAT THE COLLAR IS APPROPRIATE FOR ITS INTENDED USE. THE DESIGN IS CONSISTENT WITH ITS INTENDED USE AND THE COMPLAINT DESCRIPTION DOES NOT APPEAR TO BE RELATED TO THE PRODUCT DESIGN. A COMPLETE INVESTIGATION OF THE COMPLAINT DESCRIPTION ABOVE HAS BEEN CONDUCTED ON PREVIOUS COMPLAINTS AND 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. INCORRECT 510K CHOSEN ON INITIAL SHOULD BE K091689. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING L2-ILIUM FUSION PROCEDURE, AS THE SURGEON WAS TORQUING THE NUTS FOR THE FINAL TIGHTENING, 3 OF THE COLLARS BROKE AND ALL PIECES WERE RETRIEVED BY THE SURGEON. THIS HAPPENED ON 3 OF THE 12 NUTS AND COLLARS BEING USED IN THE CONSTRUCT. THE SURGEON THEN SELECTED 3 MORE COLLARS AND NUTS AND WAS ABLE TO COMPLETE THE PROCEDURE WITHOUT FURTHER INCIDENT. EVENT #1 OF 4 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    THIS REPORT WHICH IS REPORT 1 OF 4 FOR COMPLAINT (B)(4) IS FOR THREE TI COLLARS WITH GROOVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172094 TI COLLAR WITH GROOVES MNI SYNTHES BRANDYWINE 6904941

    Patients

    Seq Age Sex Outcome Treatment
    1