BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERNALOCK 360 STERNAL CLOSURE SYSTEM

    MDR report key: 16371201 · Received February 14, 2023

    Report

    Report Number
    16371201
    Event Type
    Malfunction
    Date Received
    February 14, 2023
    Date of Event
    February 3, 2023
    Report Date
    February 6, 2023
    Manufacturer
    BIOMET MICROFIXATION, INC
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    MD ATTEMPTING TO TIGHTEN THE ZIMMER BIOMET STERNALOCK 360 STERNAL WIRE PLATING DEVICE WHEN THE BLACK TIGHTENING PIECE SLIPPED OFF THE FIRST WIRE. THE SAME EVENT HAPPENED WHEN SHE ATTEMPTED TO TIGHTEN THE SECOND WIRE. THE THIRD WIRE TIGHTENED WITHOUT ISSUE. SHE WAS UNABLE TO REPLACE THE BLACK TIGHTENING PIECES. BOTH FAILED PIECES WERE REMOVED. A SECOND 360 DEVICE WAS OPENED AND BOTH WIRES WERE REPLACED AND TIGHTENED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720670 STERNALOCK 360 STERNAL CLOSURE SYSTEM PLATE, FIXATION, BONE HRS BIOMET MICROFIXATION, INC 74-0004 249730

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown