BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATRIXMANDIBLE SHORT CUT PLATE CUTTER

    MDR report key: 7191647 · Received January 15, 2018

    Report

    Report Number
    2939274-2018-50268
    Event Type
    Malfunction
    Date Received
    January 15, 2018
    Date of Event
    December 19, 2017
    Report Date
    December 19, 2017
    Manufacturer
    WRIGHTS LANE : SYNTHES USA PRODUCTS LLC
    Product Code
    HTZ
    UDI-DI
    10887587011783
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART # 03.503.057, LOT # 3013415. MANUFACTURING LOCATION: (B)(4), RELEASE TO WAREHOUSE DATE: DEC 10, 2008. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. PRODUCT DEVELOPMENT INVESTIGATION WAS COMPLETED. AT CUSTOMER QUALITY (CQ), THE PLATE CUTTER WAS INSPECTED AND THE COMPLAINT OF BROKEN CUTTER HEAD WAS CONFIRMED. VISUAL INSPECTION PERFORMED AT CUSTOMER QUALITY OBSERVED THAT THE CUTTER HEAD BROKE AT THE REGION PROXIMAL TO THE TOP PLATE HOLDING PIN. HOLDING PIN IS STILL RETAINED IN THE ASSEMBLY. THE CUTTING SURFACE OF BROKEN PIECE SHOW SLIGHTLY DEFORMED EDGES ON THE OUTER HALF OF THE SLOT. BROKEN PIECE OF CUTTER HEAD WAS ALSO RETURNED. NO NEW MALFUNCTIONS HAVE BEEN IDENTIFIED. WHETHER THIS COMPLAINT COULD BE REPLICATED IS NOT APPLICABLE BECAUSE THE DEVICE WAS RETURNED BROKEN. RELEVANT DRAWINGS FOR THE RETURNED DEVICE WERE REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN AND APPLICATION WHEN USED AS RECOMMENDED. DIMENSIONAL ANALYSIS PERFORMED AT CUSTOMER QUALITY, MEASURED THICKNESS AT THE BROKEN CROSS SECTION TO BE 9.49 MM (CALIPERS CA592) WHICH FALLS WITHIN SPECIFICATION OF 9.4 MM TO 9.6 MM BASED ON THE DRAWINGS. DIMENSIONAL CHANGES TO THE CUTTING FEATURE WERE MADE TO IMPROVE THE STRENGTH OF THE CUTTER HEAD WITH AN UPDATED DRAWING RELEASED FOR THE CUTTER HEAD IN APRIL 2010. SINCE THE DEVICE WAS MANUFACTURED PRIOR TO THE DESIGN CHANGE, THE DEVICE DESIGN LIKELY CONTRIBUTED TO THE COMPLAINT CONDITION. THE CURRENT DESIGN WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. THEREFORE, FROM A DESIGN PERSPECTIVE THIS COMPLAINT IS VALID BUT IS ALREADY BEING ADDRESSED UNDER RELEVANT ACTIONS. A DEVICE HISTORY REVIEW, INCLUDING MATERIAL AND HARDNESS REVIEWS, WAS PERFORMED FOR THE RETURNED INSTRUMENT¿S LOT NUMBER AND NO NON-CONFORMANCE REPORTS, MATERIAL REVIEW REPORTS OR COMPLAINT-RELATED ISSUES WERE IDENTIFIED WITH THE LOT NUMBER WHICH MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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

    PATIENT WEIGHT NOT AVAILABLE FOR REPORTING. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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 DURING A FREE FLAP RECONSTRUCTION ON (B)(6) 2017, WHILE ATTEMPTING TO CUT THE RECONSTRUCTION PLATE, THE MATRIXMANDIBLE SHORT CUT PLATE CUTTER SHEARED OFF AT THE TIP. THE EVENT OCCURRED INTRAOPERATIVELY BUT AWAY FROM THE PATIENT ON A BACK TABLE. ANOTHER SHORT CUT PLATE CUTTER WAS OBTAINED TO COMPLETE THE CUTTING OF THE RECONSTRUCTION PLATE. NO ADDITIONAL X-RAYS OR MEDICAL INTERVENTIONS WERE NEEDED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 3 MINUTES. PATIENT STATUS WAS NOTED AS STABLE. CONCOMITANT DEVICE REPORTED: RECONSTRUCTION PLATE (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) MATRIXMANDIBLE SHORT CUT PLATE CUTTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33969 MATRIXMANDIBLE SHORT CUT PLATE CUTTER INSTRUMENT,CUTTING,ORTHOPAEDIC HTZ WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 3013415 10887587011783

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR