BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLDING SLEEVE-LONG FOR MATRIX

    MDR report key: 3050757 · Received April 10, 2013

    Report

    Report Number
    1719045-2013-10639
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    November 1, 2011
    Report Date
    November 1, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    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 SYNTHES DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. PRODUCT DEVELOPMENT EVALUATION REVEALED RETURNED DEVICE WAS RECEIVED WITH THE FIRST THREAD ON THE DISTAL END BROKEN OFF AND THE REMAINING THREADS HAVE DENTS AND BURRS. THE TIP CANNOT BE INSERTED INTO A SCREW DUE TO THE DAMAGE. THE BROKEN THREAD PIECE IS IN THE RETURNED POLYAXIAL SCREW THREAD RECESS. 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 THE EVALUATION THAT THE CONDITION OF THE THREADS INDICATES 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. A COMPANY CORRECTIVE AND PREVENTIVE ACTION WAS INITIATED TO ADDRESS THIS ISSUE.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LUMBAR FUSION PROCEDURE AT L3-L5 THE TIP OF THE HOLDING SLEEVE AND THE TIP OF THE SCREWDRIVER BROKE OFF IN THE HEAD OF A SCREW DURING INSERTION. ALL PIECES WERE REMOVED FROM THE PATIENT. THE SURGEON USED ANOTHER HOLDING SLEEVE, SCREWDRIVER AND A NEW SCREW TO COMPLETE THE PROCEDURE. THIS IS REPORT 2 OF 2 FOR THE SAME EVENT.

    Description of Event or Problem · 1

    THIS IS REPORT 2 OF 2 FOR THIS COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149636 HOLDING SLEEVE-LONG FOR MATRIX LXH SYNTHES MONUMENT 6489807

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR