BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIBERSTITCH¿ IMPLANT, 24° CURVE WITH TWO POLYESTER IMPLANTS AND 2-0 FIBERWIRE® S

    MDR report key: 19679744 · Received July 5, 2024

    Report

    Report Number
    19679744
    Event Type
    Malfunction
    Date Received
    July 5, 2024
    Date of Event
    February 20, 2024
    Report Date
    February 21, 2024
    Manufacturer
    T.A.G. MEDICAL PRODUCTS CORPORATION LTD
    Product Code
    MBI
    UDI-DI
    10818674025703
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NV
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PT CAME IN FOR RIGHT KNEE ARTHROSCOPY ACL REPAIR. IN THE MIDDLE OF SURGERY, FIBERSTITCH TIP BROKE OFF INSIDE PT. AND MD RETRIEVED THE BROKEN PIECE AND CASE CONTINUED. PT DISCHARGED TO PACU IN STABLE CONDITION. ENTIRE FIBERSTITCH UNIT RETRIEVED AND GIVEN TO NURSE MANAGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491196 FIBERSTITCH¿ IMPLANT, 24° CURVE WITH TWO POLYESTER IMPLANTS AND 2-0 FIBERWIRE® S FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI T.A.G. MEDICAL PRODUCTS CORPORATION LTD AR-4570-24 21N09 10818674025703

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male