BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLDING SLEEVE-LONG FOR MATRIX

    MDR report key: 2993618 · Received March 7, 2013

    Report

    Report Number
    1719045-2013-10302
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    November 22, 2011
    Report Date
    November 23, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE PRODUCT DEVELOPMENT EVALUATION REVEALED THAT THE CONDITION APPEARS TO BE THE RESULT OF THE SLEEVE BECOMING LOOSE DURING SCREW INSERTION WHICH CONTRIBUTED TO THE THREAD BREAKAGE OR DAMAGE. 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. AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED TO ADDRESS THE ROOT CAUSE OF 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.

    Description of Event or Problem · 1

    SYNTHES (B)(4) SPINE PRODUCT MANAGER REPORTED THAT DURING A LUMBAR FUSION AND DECOMPRESSION CASE, THE CONSULTANT EXAMINED TWO MATRIX HOLDING SLEEVES THAT WERE NOT FUNCTIONING PROPERLY. THE STANDARD SLEEVE ((B)(4)) HAS A PIECE BROKEN OFF FROM THE THREADED TIP ON ONE SIDE AND WILL NOT ENGAGE INTO THE BONE SCREW. THE LONG SLEEVE ((B)(4)) THE THREADS HAVE ROUNDED OFF AT THE TIP AND WILL NOT ENGAGE AT THE TIP. THIS REPORT IS ON THE HOLDING SLEEVE-LONG FOR MATRIX THIS IS REPORT 2 OF 2 FOR THIS 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
    97016 HOLDING SLEEVE-LONG FOR MATRIX LXH SYNTHES MONUMENT 6489803

    Patients

    Seq Age Sex Outcome Treatment
    1