BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEWI CLAMP

    MDR report key: 24058702 · Received January 13, 2026

    Report

    Report Number
    MW5182189
    Event Type
    Malfunction
    Date Received
    January 13, 2026
    Date of Event
    January 6, 2026
    Report Date
    January 6, 2026
    Manufacturer
    AVALIGN TECHNOLOGIES, INC.
    Product Code
    GEN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING A MAKO ASSISTED LEFT TOTAL HIP CASE, THE LEWIN CLAMP BROKE. THE SURGEON INSPECTED THE INSTRUMENT AND THE PATIENT; THE SCRUB TECH AND CIRCULATOR INSPECTED THE EQUIPMENT. SPD WAS CONTACTED TO COME AND INSPECT THE INSTRUMENT; ALL PARTIES INVOLVE AGREE THAT ALL PARTS OF THE INSTRUMENT WERE OBTAINED AND ACCOUNTED FOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124597 LEWI CLAMP FORCEPS, GENERAL & PLASTIC SURGERY GEN AVALIGN TECHNOLOGIES, INC. 0-47-130

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male