BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLDING SLEEVE-LONG FOR MATRIX

    MDR report key: 3063680 · Received April 17, 2013

    Report

    Report Number
    1719045-2013-10633
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    March 22, 2012
    Report Date
    March 22, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    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 THE PART OF THE SECOND THREAD ON THE DISTAL END HAD BROKEN OFF. THE REMAINING THREADS ARE UNDAMAGED. THE TIP CANNOT BE INSERTED INTO A SCREW DUE TO THE DAMAGE. A SCREWDRIVER SHAFT WAS INSERTED AND HELD PROPERLY IN THE HOLDING SLEEVE. 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. THIS INVESTIGATION FOUND, THE CONDITION TO BE THE RESULT OF THE SLEEVE BECOMING LOOSE DURING SCREW INSERTION WHICH CONTRIBUTED TO THE BREAKAGE. THIS IS CONSISTENT WITH PREVIOUS INVESTIGATIONS FOR THE SAME DEVICE AND THE SAME CONDITION, A CORRECTIVE ACTION HAS BEEN INITIATED TO PREVENT THIS CONDITION FROM REOCCURRING.

    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.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING A MATRIX PLIF AT L4-L5, THE SURGEON WAS INSERTING THE SCREW AND THE THREADED TIP OF THE HOLDING SLEEVE (03.632.036) BROKE OFF. THE BROKEN FRAGMENT WAS RETRIEVED AND DISCARDED. THE SURGEON USED ANOTHER HOLDING SLEEVE TO COMPLETE THE PROCEDURE WITH NO FURTHER PROBLEMS. NO ADVERSE EFFECT TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166232 HOLDING SLEEVE-LONG FOR MATRIX LXH SYNTHES MONUMENT 6490071

    Patients

    Seq Age Sex Outcome Treatment
    1