BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JUGGERKNOT SOFT ANCHORS

    MDR report key: 20332412 · Received September 30, 2024

    Report

    Report Number
    20332412
    Event Type
    Malfunction
    Date Received
    September 30, 2024
    Date of Event
    June 21, 2024
    Report Date
    June 25, 2024
    Manufacturer
    BIOMET ORTHOPEDICS, LLC
    Product Code
    MBI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    1.4 JUGGERKNOT SUTURE ANCHOR WAS DELIVERED TO STERILE FIELD IN USUAL FASHION. WHEN PHYSICIAN WENT TO USE THE DEVICE THE ANCHOR SCREW BECAME DISLODGED AND APPEARED ALTERED, WAS THEN NOT USABLE, IT APPEARS TO BE A MANUFACTURER DEFECT. ITEM#: 912030, LOT#: 0002474309, EXPIRATION DATE: 10/05/2027. REPLACED THIS ITEM WITH ONE LIKE IT AND WORKED SUFFICIENTLY. PHYSICIAN FELT IT WAS A MANUFACTURER DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2607118 JUGGERKNOT SOFT ANCHORS FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI BIOMET ORTHOPEDICS, LLC 912030 0002474309

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Male