BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSA EXCEL 36KHZ DISPOSABLE WRENCH

    MDR report key: 7263278 · Received February 12, 2018

    Report

    Report Number
    3006697299-2018-00006
    Event Type
    Malfunction
    Date Received
    February 12, 2018
    Date of Event
    December 8, 2017
    Report Date
    January 19, 2018
    Manufacturer
    INTEGRA LIFESCIENCES (IRELAND) LTD.
    Product Code
    LFL
    PMA / PMN Number
    K141674
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION COMPLETED ON 23FEB2018. FOUR (4) UNITS FROM (B)(4) LOT # 1170049 WERE RECEIVED FOR EVALUATION IN THE ORIGINAL PACKAGING TRAY AND WERE FOUND COMPLETELY SEALED. A BLACK PARTICLE WAS OBSERVED IN ALL UNITS. THE BLACK PARTICLES WERE LOOSE; NOT EMBEDDED. THE CAP OF THE RETURNED UNITS WERE REMOVED TO EVALUATE THE PRESENCE OF THE INTERNAL COMPONENTS AND THEIR CONDITIONS. ALL COMPONENTS (PLASTIC HUB, METAL HEX, O-RING, METAL SPRINGS) WERE PRESENT. SOME BLACK PARTICLES WERE OBSERVED AT THE BOTTOM OF THE WRENCH LIKELY THE ONE OBSERVED ON THE TRAY WHEN THEY WERE COMPARED UNDER MICROSCOPE. THE LOT COMPLIED WITH ALL IN-PROCESS INSPECTIONS AND TESTING REQUIREMENTS AS SPECIFIED IN THE MANUFACTURING SHOP ORDER AND RELATED PROCEDURES. THE REPORTED ISSUE WAS CONFIRMED. THE BLACK PARTICLES WERE COMING FROM INSIDE OF THE DEVICE WHICH IS A CONSEQUENCE OF THE TORQUE TEST PERFORMED AT THE WRENCH¿S SUPPLIER.

    Additional Manufacturer Narrative · 1

    THE DEVICES WERE NOT YET RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. LINKED TO MFG. REPORT NUMBER: 3006697299-2018-00005.

    Description of Event or Problem · 1

    TWO OF 2 REPORTS. A QUALITY ASSURANCE REPRESENTATIVE REPORTED DURING INSPECTION ON (B)(6) 2017, THE C5602 CUSA EXCEL 36KHZ DISPOSABLE WRENCH WERE INSPECTED IN TOTAL OF 210 PIECES AND REJECTED 4 PIECE BECAUSE OF FOREIGN MATERIAL NOTED. THERE WAS NO PATIENT INVOLVEMENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107565 CUSA EXCEL 36KHZ DISPOSABLE WRENCH ULTRASONIC SURGICAL PRODUCTS LFL INTEGRA LIFESCIENCES (IRELAND) LTD. 1170049

    Patients

    Seq Age Sex Outcome Treatment
    1