BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8.0MM TI MATRIX POLYAXIAL SCREW 45MM THREAD LENGTH

    MDR report key: 3031799 · Received April 2, 2013

    Report

    Report Number
    2530088-2013-10326
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    February 27, 2012
    Report Date
    February 27, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. ADD'L PRO CODES: MNH, MNI, KWQ, KWP. MANUFACTURING EVALUATION REPORTS THAT THE SAMPLE WAS RECEIVED ASSEMBLED WITH MARKS NOT CONSISTENT WITH THE MANUFACTURING OF THE INNER DIAMETER OF THE BONE SCREW HEAD. THE STAR DRIVE SHOWS SOME WEAR AND THE INNER DIAMETER THREAD OF THE SCREW HEAD IS BROKEN. DUE TO THE ITEM RETURNED IN THE ASSEMBLED STATE, MAJORITY OF THE FEATURES RELATED TO THE COMPLAINT CONDITION COULD NOT BE EVALUATED. THE MATERIAL COULD NOT BE CHECKED FOR THE COLLET DUE TO THE ITEM IN ITS ASSEMBLED CONDITION. THE DHR SHOWS THAT THE MATERIAL WAS CORRECT AT THE TIME OF MANUFACTURE. PRODUCT DEVELOPMENT EVENT EVALUATION REVEALED THE FAILURE MECHANISM DISPLAYED BY THE DAMAGED IMPLANTS CAN ONLY BE ACHIEVED THROUGH AN APPLIED TENSILE LOAD. THE CONDITION OF THE SCREW INDICATES THAT THE ENGAGED HOLDING SLEEVE WAS PARTIALLY UNTHREADED FROM THE IMPLANT INTERFACE, AT WHICH POINT A CANTILEVER LOAD WAS APPLIED TO ASSEMBLY. THIS INCOMPLETE ENGAGEMENT ALLOWED THE CANTILEVER FORCE TO CONCENTRATE ON ONE SECTION OF THE IDENTIFIED THREADS, EXCEEDING THE DESIGN TENSILE LIMITS. NO OTHER EVIDENCE OF DAMAGE WAS OBSERVED. THE MATRIX TECHNIQUE GUIDE AS WELL AS OTHER PRODUCT SUPPORT INFORMATION ILLUSTRATES THE PROPER METHOD OF LOADING AND UNLOADING SCREWS FROM A HOLDING SLEEVE. IMPROPER REMOVAL TECHNIQUE EXCEEDING THE DESIGNS INTENDED LIMITS WAS THE CAUSE OF FAILURE, THEREFORE THIS COMPLAINT IS CONSIDERED INVALID FROM A MANUFACTURING PERSPECTIVE.

    Additional Manufacturer Narrative · 1

    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. ORIGINAL AWARENESS DATE IS 2/27/2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A POSTERIOR LUMBAR FUSION AT L4-L5, L5-S1, WHILE THE SURGEON PLACED THE FIRST SCREW, THE SCREW WOULD NOT ENGAGE. THE SURGEON THEN SELECTED THE SECOND SCREW AND THE HEAD OF THE SCREW POPPED OFF DURING SCREW INSERTION. THE SCREW HEAD WAS RETRIEVED AND THE SURGEON COMPLETED THE PROCEDURE WITH NEW SCREWS. THE PATIENT WAS UNHARMED.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134229 8.0MM TI MATRIX POLYAXIAL SCREW 45MM THREAD LENGTH NKB SYNTHES BRANDYWINE 6791742

    Patients

    Seq Age Sex Outcome Treatment
    1