BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VANGUARD

    MDR report key: 21376665 · Received February 13, 2025

    Report

    Report Number
    21376665
    Event Type
    Malfunction
    Date Received
    February 13, 2025
    Date of Event
    February 4, 2025
    Report Date
    February 6, 2025
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    FSM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING LEFT TOTAL KNEE REPLACEMENT, AN IMPACTOR AND A BEARING TRIAL BROKE. SEACOAST BIOMET INC. IMPACTOR WAS FROM GENERAL INSTRUMENT TRAY- MARLBORO KNEE 1 OR 7 2621 #59530.WHILE USING THE IMPACTOR THE PLASTIC PIECE OF THE IMPACTOR BROKE IN HALF. NO HARM TO THE PATIENT. THE BEARING TRIAL 63/67 X10 GREEN TRIAL WHILE USING ON THE PATIENT A SMALL PIECE BROKE OFF THE TRIAL. NO HARM TO THE PATIENT. ALL PIECES WERE ACCOUNTED FOR IN THEIR ENTIRETY AND NO PIECES WERE LEFT IN THE PATIENT. THE BEARING TRAIL CAME FROM THE UNIVERSAL 5 IN 1 BEARING TRIAL TRAY 4363 # 595338. THE BROKE IMPACTOR AS WELL AS THE BROKEN TRIAL WAS REMOVED FROM THE STERILE FIELD. [REDACTED NAME] BIOMET WAS AWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105214 VANGUARD TRAY, SURGICAL, INSTRUMENT FSM BIOMET ORTHOPEDICS 595338

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Female