BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEWIN CLAMP

    MDR report key: 4192832 · Received October 16, 2014

    Report

    Report Number
    MW5038710
    Event Type
    Malfunction
    Date Received
    October 16, 2014
    Date of Event
    October 14, 2014
    Report Date
    October 16, 2014
    Manufacturer
    BOSS INSTRUMENTS, LTD
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2014, A LEWIN CLAMP BROKE DURING THE EXTRACTION OF THE FEMORAL HEAD DURING A RIGHT TOTAL HIP ARTHROPLASTY. THE CLAMP BROKE OFF AT THE 'JUNCTION' WHERE THE PINCHER COMPONENT WIDENS AT THE MID-SECTION ("Y") OF THE CLAMP PROXIMAL TO THE HANDLES. X-RAY REVEALED A SMALL FLECK OF THE METAL IN THE SUBCUTANEOUS TISSUES JUST LATERAL TO THE GREATER TROCHANTER. THE SURGEON DETERMINED THE RISK OF REMOVAL DID NOT WARRANT FURTHER EXPLORATION (MORBIDITY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658955 LEWIN CLAMP LEWIN CLAMP LXH BOSS INSTRUMENTS, LTD 27-0820

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR