BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLDING SLEEVE-STANDARD FOR MATRIX

    MDR report key: 3082866 · Received April 29, 2013

    Report

    Report Number
    1719045-2013-10969
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    August 6, 2012
    Report Date
    August 6, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    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. A REVIEW OF DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. PRODUCT DEVELOPMENT EVALUATION STATED THAT THE FIRST FULL THREAD AND APPROXIMATELY HALF OF THE SECOND THREAD ARE DAMAGED WITH THE CROWNS BEING SCORED AND BURRS ROSE TOWARD THE DISTAL TIP. THERE IS A CRACK AT THE ROOT BETWEEN THE FIRST AND SECOND THREAD ON ONE SIDE AND THE THREAD IN THAT AREA IS BENT UP TOWARD THE TIP. THE TIP COULD NOT BE THREADED INTO A NEW MATRIX SCREW. THE TECHNIQUE GUIDE ILLUSTRATES HOW TO PROPERLY LOAD AND TIGHTEN THE HOLDING SLEEVE INTO THE RECESS OF THE SCREW AND CAUTIONS NOT TO GRASP THE GREEN KNOB DURING SCREW INSERTION AS THIS WILL CAUSE THE HOLDING SLEEVE TO DISENGAGE FROM THE SCREW. THE DAMAGE IS CONSISTENT WITH THAT NOTED IN PREVIOUS COMPLAINTS AND THE EVALUATIONS OF THOSE HAVE NOTED THE CONDITION OF THE THREADS INDICATED THAT THE ENGAGED HOLDING SLEEVE WAS PARTIALLY UNTHREADED FROM THE IMPLANT INTERFACE, AT WHICH POINT A CANTILEVER LOAD WAS APPLIED TO THE ASSEMBLY. THIS INCOMPLETE ENGAGEMENT ALLOWED THE CANTILEVER FORCE TO CONCENTRATE ON ONE SECTION OF THE THREADS, EXCEEDING THE DESIGN LIMITS. AN INTERNAL CORRECTIVE ACTION WAS INITIATED TO ADDRESS THE SLEEVE BECOMING LOOSE DURING SCREW INSERTION WHICH CONTRIBUTED TO THE BREAKAGE AND PREVENT THIS CONDITION FROM REOCCURRING.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. 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.(B)(4)

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER DURING A L5-S1 PLIF PROCEDURE, THE SURGEON WAS PLACING THE L5 SCREW ON THE LEFT. SURGEON WAS TRYING TO REDIRECT THE SCREW BY APPLYING ADDITIONAL PRESSURE TO REPOSITION IT. AS HE DID, THE HOLDING SLEEVE PULLED OUT OF THE HEAD OF THE BONE SCREW AND THE THREADS WERE DAMAGED. THE HOLDING SLEEVE WILL NO LONGER HOLD SCREWS. THIS IS 1 OF 1 REPORT FOR EVENT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184465 HOLDING SLEEVE-STANDARD FOR MATRIX LXH SYNTHES MONUMENT 6611821

    Patients

    Seq Age Sex Outcome Treatment
    1