BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATRIXNEURO INSTRUMENT MODULE

    MDR report key: 6011754 · Received October 7, 2016

    Report

    Report Number
    2520274-2016-14835
    Event Type
    Malfunction
    Date Received
    October 7, 2016
    Report Date
    September 19, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    FSM
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. NO PATIENT INVOLVEMENT. UDI#: (B)(4) LOT NUMBER. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THREE (3) MATRIXNEURO COMPACT MODULES (PART 306.501 / LOT NUMBERS UNKNOWN) AND THREE (3) MATRIXNEURO INSTRUMENT MODULES (PART 306.502 / LOT NUMBERS UNKNOWN) WERE RECEIVED. A VISUAL INSPECTION AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE COMPLAINT CONDITION IS CONFIRMED. THE COMPACT MODULES WERE EACH RECEIVED THE FOUR FEET RESPONSIBLE FOR CONNECTING TO THE INSTRUMENT MODULE BROKEN OFF OR GOUGED. THE INSTRUMENT MODULES WERE EACH RECEIVED THE TRAY INSTRUMENT SLIDE COMPONENT (306.526) NO LONGER BEING PROPERLY RETAINED DUE TO BREAKAGE OF BOTH OF THE LOCKING TABS ON EACH COMPONENT. THE FUNCTION OF THESE TABS IS TO SECURE THE DRAWER IN PLACE. THE BUTTONS THAT CONNECT WITH THE COMPACT MODULE COULD BE DEPRESSED AS INTENDED TO SEPARATE THE TWO MODULES AND ALLOWED THE MODULES TO BE REASSEMBLED. ALL OF THE RETURNED MODULES EXHIBIT SIGNIFICANT WEAR AND NOTICEABLE DAMAGE INDICATIVE OF HEAVY USAGE OVER TIME. IMPACT MARKS, NICKS, AND GOUGES WERE OBSERVED. STICKERS AND STICKY RESIDUE WAS ALSO NOTED. EACH OF THE RETURNED COMPACT MODULES WAS RECEIVED TAPED TO A CORRESPONDING INSTRUMENT MODULE. THE BROKEN PORTIONS WERE NOT RECEIVED. DUE TO THE DAMAGE, THE MODULES DO NOT HOLD TOGETHER AS INTENDED. THUS, THE COMPLAINT CONDITION IS CONFIRMED AND CONSISTENT WITH THE REPORTED CONDITION. REPLICATION OF THE COMPLAINT CONDITION IS NOT APPLICABLE AS THE DEVICES ARE ALREADY BROKEN. (ALL DIMENSIONAL INSPECTIONS COMPLETED WITH A CALIPER.) A FOURTH COMPACT MODULE AND INSTRUMENT MODULE WERE ALSO REPORTED BUT WERE NOT RETURNED FOR EVALUATION. IT WAS CONFIRMED THAT THE FOURTH MATRIX NEURO SET WAS DISCARDED BY THE HOSPITAL. THESE MODULES ARE PART OF THE MATRIXNEURO SYSTEM AND CLIP TOGETHER TO FORM A FULL GRAPHIC CASE. INFORMATION REGARDING THIS SYSTEM IS PROVIDED PER THE NEXT GENERATION CRANIAL PLATING SYSTEM MATRIXNEURO TECHNIQUE GUIDE. RECOMMENDATIONS FOR HANDLING, TRANSPORTATION, AND REPROCESSING ARE PROVIDED BY THE GRAPHIC CASE MAINTENANCE AND CARE QUICK REFERENCE. THE DEVICES ARE ETCHED ¿306.501-REV G¿ AND 306.502-REV D¿ RESPECTIVELY. THUS, A REVIEW OF THE CURRENT DESIGN DRAWING / MANUFACTURED REVISION FOR EACH DEVICE WAS PERFORMED. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE RETURNED PARTS WERE DETERMINED TO BE SUITABLE FOR THEIR INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. ALL OF THE RETURNED MODULES EXHIBIT SIGNIFICANT WEAR AND NOTICEABLE DAMAGE INDICATIVE OF HEAVY USAGE OVER TIME. IMPACT MARKS, NICKS, AND GOUGES WERE OBSERVED. THIS CONDITION IS CONSISTENT WITH ROUGH HANDLING, IMPACT WITH OTHER DEVICES AND/OR SURFACES, AND FORCEFUL SEPARATION OF THE MODULES WITHOUT FULLY DEPRESSING THE RELEASE BUTTONS. THE BROKEN COMPACT MODULE FEET AND INSTRUMENT MODULE TABS ARE THE RESULT OF FORCE BEYOND THE YIELD STRENGTH OF THE MATERIAL WHICH WOULD NOT BE EXPECTED DURING RECOMMENDED USE. HOWEVER, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED GIVEN THE UNKNOWN CIRCUMSTANCES AT THE TIME OF THE ISSUE AND PREVIOUSLY ACCUMULATED WEAR/DAMAGE. RECOMMENDATIONS FOR HANDLING, TRANSPORTATION, AND REPROCESSING ARE PROVIDED BY THE GRAPHIC CASE MAINTENANCE AND CARE QUICK REFERENCE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CLIPS ON THE SIDE OF THE MATRIXNEURO COMPACT MODULE AND THE CLIPS ON THE SIDE OF THE MATRIXNEURO INSTRUMENT MODULE ARE BROKEN; THE MODULES LOCK TOGETHER TO MAKE A TRAY. THE LEG CLIPS ON THE COMPACT MODULE AND THE RECEIVING ARM CLIPS ON THE INSTRUMENT MODULE BROKE AT THE JUNCTION THAT HOLDS THE TWO MODULES TOGETHER. THE MODULES WILL NOT LOCK TOGETHER AND TAPE WAS BEING USED TO HOLD THE MODULES TOGETHER. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS 7 OF 8 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662667 MATRIXNEURO INSTRUMENT MODULE TRAY, SURGICAL INSTRUMENT FSM SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1