BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRVANCE¿ THS SYSTEM - TOUNGE SUSPENSION KIT

    MDR report key: 5123619 · Received October 2, 2015

    Report

    Report Number
    1045254-2015-00319
    Event Type
    Malfunction
    Date Received
    October 2, 2015
    Date of Event
    September 8, 2015
    Report Date
    September 8, 2015
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    LRK
    PMA / PMN Number
    K981677
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: 76353200M: AIRVANCE THS SYSTEM; MANUFACTURED DATE - DECEMBER 22, 2014; LOT NUMBER - 0209093563; EXPIRATION DATE - DECEMBER 21, 2016; 510K NUMBER - K981677. (B)(4). SAMPLE 1: THE PRODUCT ANALYSIS INDICATES THAT WHEN COMPARED TO THE ASSEMBLY DRAWING AND SCREW ASSEMBLY DRAWING, THE SUTURE WAS VISIBLE AT THE PROXIMAL END OF THE HANDPIECE HOWEVER THE THREADS OF THE SCREW WERE NOT VISIBLE AT THE DISTAL END, WHICH WOULD HAVE RESULTED IN THE REPORTED EVENT. WHEN VIEWED UNDER MAGNIFICATION, IT WAS DETERMINED THAT THE DISTAL TIP OF THE SCREW HAD BROKEN OFF AND THE PROXIMAL END OF THE SCREW ATTACHED TO THE SUTURE WAS STILL IN THE HANDPIECE. THE DISTAL END OF THE SCREW WAS NOT RETURNED WHICH WOULD HAVE MEASURED APPROXIMATELY 4MM IN LENGTH. THE HANDPIECE WAS SWITCHED TO THE READY MODE AND THE TRIGGER ACTIVATED THE ROTATION. THE SCREW AND SUTURE ASSEMBLY IS A SUPPLIED MATERIAL ASSEMBLY, THEREFORE MANUFACTURING IS RULED OUT AS A LIKELY CAUSE. WHEN VIEWED UNDER MAGNIFICATION, THE BREAK POINT CONTAINED CIRCULAR PATTERNS THAT MAY INDICATE EXCESS TORSIONAL LOADS (EXCESS = EXCEEDED SUFFICIENT PRESSURE REQUIRED FOR OPERATION). SAMPLE 2: THE PRODUCT ANALYSIS INDICATES THAT WHEN COMPARED TO THE ASSEMBLY DRAWING AND SCREW ASSEMBLY DRAWING, THE SUTURE WAS VISIBLE AT THE PROXIMAL END OF THE HANDPIECE HOWEVER THE THREADS OF THE SCREW WERE NOT VISIBLE AT THE DISTAL END, WHICH WOULD HAVE RESULTED IN THE REPORTED EVENT. WHEN VIEWED UNDER MAGNIFICATION, IT WAS DETERMINED THAT THE DISTAL TIP OF THE SCREW HAD BROKEN OFF AND THE PROXIMAL END OF THE SCREW ATTACHED TO THE SUTURE WAS STILL IN THE HANDPIECE. THE DISTAL END OF THE SCREW WAS NOT RETURNED WHICH WOULD HAVE MEASURED APPROXIMATELY 4MM IN LENGTH. THE HANDPIECE WAS SWITCHED TO THE READY MODE AND THE TRIGGER ACTIVATED THE ROTATION. THE SCREW AND SUTURE ASSEMBLY IS A SUPPLIED MATERIAL ASSEMBLY THEREFORE MANUFACTURING IS RULED OUT AS A LIKELY CAUSE. WHEN VIEWED UNDER MAGNIFICATION, THE BREAK POINT CONTAINED CIRCULAR PATTERNS THAT MAY INDICATE EXCESS TORSIONAL LOADS (EXCESS = EXCEEDED SUFFICIENT PRESSURE REQUIRED FOR OPERATION). THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES.

    Description of Event or Problem · 1

    INTRAOPERATIVE, TWO AIRVANCE SYSTEMS (SAME LOT NUMBER) FAILED. THE FIRST AIRVANCE SYSTEM'S SCREW BROKE INTO TWO PIECES AFTER IT HAD BEEN IMPLANTED INTO THE PATIENT. THE SECOND AIRVANCE SYSTEM'S SUTURE RUPTURED WHEN THE SURGEON WAS MAKING FINAL KNOTS. THERE WAS NO INJURY REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656489 AIRVANCE¿ THS SYSTEM - TOUNGE SUSPENSION KIT DEVICE, ANTI-SNORING LRK MEDTRONIC XOMED INC. 76353200M 0209093563

    Patients

    Seq Age Sex Outcome Treatment
    1