BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSATAP SUTURE ANCHOR

    MDR report key: 23053745 · Received September 15, 2025

    Report

    Report Number
    MW5176072
    Event Type
    Malfunction
    Date Received
    September 15, 2025
    Report Date
    September 10, 2025
    Manufacturer
    ORTHO-DESIGN
    Product Code
    MBI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    (1) ORTHO-DESIGN IS A FDA LICENSED NON USA MEDICAL DEVICE ESTABLISHMENT WHICH OUTSOURCES STERILIZATION TO A NON FDA LICENSED ESTABLISHMENT -- STERI SOLUTIONS, A NON FDA LICENSED COMPONENT MANUFACTURER -- APEX TOOL IN CHINA AND A NON FDA LICENSED ASSEMBLY FACILITY ALTIS BIOLOGICS, K2 MEDICAL. THE PRODUCTS ARE DISTRIBUTED IN THE USA THROUGH TRIMED (2) ONE OF THEIR MOST RECENT PRODUCTS ADP050, FROM K242296, A SUTURE ANCHOR, ROUTINELY STRIPS ON THE INTRODUCER DURING INSERTION. THERE FORCE YOU NEED TO INSERT THE ANCHOR STRIPS THE ANCHOR FROM THE INTRODUCER... THE ANCHOR CAN THEREFORE NO LONGER BE INSERTED. (3) OFTEN THE SUTURE ANCHORS PIERCE THROUGH THE STERILE BARRIER SYSTEM POUCHING COMPRISING STERILITY FOR ASEPTIC PRESENTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2640314 VERSATAP SUTURE ANCHOR FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI ORTHO-DESIGN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other