BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLDING SLEEVE-STANDARD FOR MATRIX

    MDR report key: 3013271 · Received March 20, 2013

    Report

    Report Number
    1719045-2013-10373
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    August 29, 2011
    Report Date
    August 29, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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.(B)(4).

    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. THE PRODUCT DEVELOPMENT EVENT EVALUATION SHOWED THE FAILURE MECHANISM DISPLAYED BY THE DAMAGED INSTRUMENT CAN ONLY BE ACHIEVED THROUGH AN APPLIED TENSILE LOAD. THE CONDITION OF THE HOLDING SLEEVE THREADS INDICATES THAT WHILE ENGAGING THE IMPLANT INTERFACE A CANTILEVER LOAD WAS APPLIED TO ASSEMBLY. THIS CANTILEVER FORCE CAUSED A LOAD CONCENTRATION ON THE INITIAL SECTION OF THE IDENTIFIED THREADS, EXCEEDING THE DESIGN¿S TENSILE LIMITS. NO OTHER EVIDENCE OF DAMAGE WAS OBSERVED.THE MATRIX TECHNIQUE GUIDE AS WELL AS OTHER PRODUCT SUPPORT INFORMATION FULLY ILLUSTRATES THE PROPER METHOD OF LOADING / UNLOADING SCREWS FROM A HOLDING SLEEVE. EVIDENCE INDICATES AN IMPROPERLY AGGRESSIVE SURGEON TECHNIQUE EXCEEDING THE DESIGN¿S INTENDED LIMITS WAS THE CAUSE OF FAILURE.

    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. THE DHR WAS REVIEWED AND NO ISSUES THAT WOULD HAVE RESULTED IN THIS COMPLAINT WERE FOUND. THE PRODUCT EVALUATION VISUAL INSPECTION REVEALED THAT THE DEVICE WAS RETURNED WITH HALF OF THE FIRST THREAD BROKEN OFF. IT WAS IDENTIFIED UNDER MAGNIFICATION THAT THE BACK TWO THREADS WERE FLATTENED. THERE ARE AXIAL SCRATCHES ON THE SHAFT INDICATING USE. THE BREAK CAUSED THE MATERIAL AT THE TIP TO IMPEDE THE SHAFT, WHICH STOPPED THE 4.66MM PIN FROM PASSING THROUGH. ALL OTHER MEASURABLE DIMENSIONS ARE WITHIN PRINT SPECIFICATION. THIS COMPLAINT IS INVALID FROM A MANUFACTURING STANDPOINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PLIF PROCEDURE AT L3-L4, THE SURGEON WAS TRYING TO LOOSEN THE LOCKING SCREW TO REPOSITION THE SCREW AND THE TIP OF THE SCREWDRIVER BROKE. THE PIECE WAS RETRIEVED AND THE SURGEON USED ANOTHER TO COMPLETE THE PROCEDURE. DURING THIS SAME PROCEDURE, THE HANDLE OF THE STARDRIVE SCREWDRIVER T25 WITH T-HANDLE CAME LOOSE. THE SURGEON USED ANOTHER INSTRUMENT AND THE PROCEDURE WAS COMPLETED. THIS IS 3 OF 3 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115657 HOLDING SLEEVE-STANDARD FOR MATRIX LXH SYNTHES MONUMENT 6489720

    Patients

    Seq Age Sex Outcome Treatment
    1