BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERNALOCK 360 MULTI-IMPLANT SYSTEM

    MDR report key: 8179095 · Received December 19, 2018

    Report

    Report Number
    0001032347-2018-00878
    Event Type
    Malfunction
    Date Received
    December 19, 2018
    Date of Event
    November 26, 2018
    Report Date
    February 15, 2019
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    PMA / PMN Number
    K163007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. THE SL360 MULTI-IMPLANT SYSTEM (PART# 74-0004, LOT# 253110) WAS RETURNED IN A RED BIOHAZARD BAG. THE PARTS WERE CAREFULLY REMOVED FROM THE BAG FOR FURTHER INVESTIGATION. THE TENSIONER, METAL BAND, AND X-PLATE ALL HAD RED RESIDUE ON THEM, INDICATING THAT THEY HAD BEEN USED IN AN OPERATION. TENSIONING STEPS 1 AND 2 HAD CLEARLY BEEN COMPLETED, AS A PORTION OF THE METAL BAND HAD BEEN INSERTED UP THROUGH THE TENSIONING TOWER, LOCKED BY PRESSING THE THUMB CAM, AND THE THREADED SHAFT HAD TRAVELED WHICH INDICATES THE TIGHTENING WHEEL HAD BEEN ROTATED TO ACHIEVE FULL APPROXIMATION. THE LOCKING MECHANISM WAS NOT IN THE LOCKED POSITION WHICH SHOULD HAVE BEEN ACHIEVED DURING STEP 3. THE OBSERVED BAND FAILURE AND LOCKING MECHANISM FAILURE IS CONSISTENT WITH A FAILURE THAT WAS RECREATED WITH A NEW TENSIONING DEVICE WHEN STEP 3 WAS ATTEMPTED WITH THE LOCKING MECHANISM WAS NOT PROPERLY ENGAGED WITH TOWER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO THE LOCKING MECHANISM WAS NOT ENGAGED PROPERLY WITH THE TOWER DURING STEP 3, CAUSING THE BAND TO BE CUT BUT NOT LOCKED INTO THE INTENDED POSITION. THE INSTRUCTIONS FOR USE (IFU) FOR THIS DEVICE PROVIDES INSTRUCTIONS ON HOW TO PROPERLY USE THE TENSIONER, IN THE SECTION TITLED 'TENSIONER': A TENSIONER IS PROVIDED PRE-ASSEMBLED ON EACH IMPLANT. DIRECTIONS FOR USE OF THE TENSIONER ONCE THE CERCALGE BAND HAS BEEN PASSED THROUGH THE TENSIONER AND THE STERNAL HALVES HAVE BEEN APPROXIMATED AS CLOSE AS POSSIBLE: STEP 1: PUSH THUMB LOCK UP TO HOLD INITIAL TENSION OF THE BAND. STEP 2: ROTATE DIAL CLOCKWISE TO FULLY APPROXIMATE STERNAL HALVES. NOTE: SHOULD TENSION NEED TO BE READJUSTED DURING INTRA-OPERATIVE PLACEMENT, ROTATE DIAL COUNTER-CLOCKWISE TO ITS STARTING POSITION AND PUSH THUMB LOCK DOWN TO RELEASE TENSION. RE-APPROXIMATE BY REPEATING STEPS 1-2. STEP 3: TURN THE PADDLE CLOCKWISE TWO FULL REVOLUTIONS TO LOCK THE DEVICE AND CUT THE BAND. STEP 4: PLACE INDEX AND MIDDLE FINGER UNDER T HANDLE WITH THE TENSIONER IN THE PALM OF YOUR HAND AND LIFT UP FINGERS TO REMOVE TENSIONER FROM THE IMPLANT. A SUMMARY OF THE INVESTIGATION WAS SENT TO THE COMPLAINANT CONVEYING PROPER SURGICAL TECHNIQUE AND USE OF THE DEVICE. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). UNIQUE IDENTIFIER (UDI) #: (B)(4). PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE BAND OF THE X-PLATE, WHICH WAS PLACED ON THE BODY OF THE STERNUM, BROKE DURING STEP 3 OF THE TENSIONING DEVICE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1019475 STERNALOCK 360 MULTI-IMPLANT SYSTEM PLATE, FIXATION, BONE HRS BIOMET MICROFIXATION N/A 253110

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR