BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING HOLDING SLEEVE- STANDARD FOR MATRIX

    MDR report key: 3083782 · Received April 29, 2013

    Report

    Report Number
    1719045-2013-10992
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    August 7, 2012
    Report Date
    August 7, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS
    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 DEVICE EVENT EVALUATION STATED THAT ACCORDING TO THE COMPLAINT DESCRIPTION, THE HOLDING SLEEVE THREADS CRACKED WHILE THE SURGEON WAS TRYING TO REMOVE THE SLEEVE. THE BROKEN THREAD LOCATION INDICATES THAT THE ENGAGED HOLDING SLEEVE WAS PARTIALLY UNTHREADED FROM THE IMPLANT INTERFACE, AT WHICH POINT A CANTILEVER LOAD WAS APPLIED TO ASSEMBLY. THE HOLDING SLEEVE SHOULD HAVE COMPLETELY UNTHREADED UNLESS THE THREADS WERE CROSSTHREADED OR THE LOCKING RING COULD HAVE BEEN IN THE DOWN POSITION PRE-MATURELY AND THEREFORE THE HOLDING SLEEVE COULD HAVE APPEARED TO BE STUCK. THERE WERE NO SIGNS OF CROSSTHREADING AND THERE IS NO WAY OF KNOWING WHETHER THE FAILURE OCCURRED DUE TO THE LOCKING RING BEING PLACED IN THE DOWN POSITION PRE-MATURELY. AS THE IMPLANT WAS NOT RETURNED, NOR THE BROKEN PORTION OF THE THREAD, IT IS NOT CLEAR HOW THE HOLDER WAS THREADED INTO THE IMPLANT. THE MATRIX TECHNIQUE DESCRIBES THE PROPER WAY OF LOADING AND UNLOADING THE SCREWS ON THE HOLDING SLEEVE. THEREFORE THIS COMPLAINT IS DEEMED INDETERMINATE.

    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

    CONSULTANT REPORTED: ON A L5-S1 FUSION PROCEDURE, AS THE SURGEON WAS INSERTING THE 4TH (FINAL) SCREW INTO L5, HE TRIED TO MEDIALIZE THE SCREW. WHEN HE REMOVED THE HOLDING SLEEVE HE HAD TO APPLY ADDITIONAL PRESSURE TO THE HOLDING SLEEVE, CAUSING THE THREADS ON THE HOLDING SLEEVE TO BECOME DAMAGED. SOME FRAGMENTS OF THE THREADS BROKE OFF INTO THE HEAD OF THE SCREW. FRAGMENTS OF THE THREADS WERE RETRIEVED WHICH WAS CONFIRMED BY FLUORO. SURGEON USED ANOTHER SCREWDRIVER TO REMOVE THE SCREW. FRAGMENTS OF THE THREADS WERE RETRIEVED WHICH WAS CONFIRMED BY FLUORO. THE SURGEON IMPLANTED ANOTHER SCREW AND COMPLETED THE PROCEDURE. NO HARM TO PATIENT. CONSULTANT WILL RETURN HOLDING SLEEVE; HOSPITAL DISCARDED THE BROKEN SCREW. THIS IS 1 OF 1 REPORT FOR EVENT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185447 LOCKING HOLDING SLEEVE- STANDARD FOR MATRIX LXH SYNTHES MONUMENT 6778558

    Patients

    Seq Age Sex Outcome Treatment
    1