BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIBERSTITCH IMPLANT, CURVED WITH TWO POLYESTER IMPLANTS AND 2-0 FIBERWIRE® SUTU

    MDR report key: 19999663 · Received August 19, 2024

    Report

    Report Number
    19999663
    Event Type
    Malfunction
    Date Received
    August 19, 2024
    Date of Event
    June 13, 2024
    Report Date
    August 5, 2024
    Manufacturer
    T.A.G. MEDICAL PRODUCTS CORPORATION LTD
    Product Code
    MBI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    NEEDLE BROKE INSIDE THE PATIENT'S LEFT KNEE WHILE ARTHREX FIBERSTITCH DEVICE WAS IN USE. DEVICE NAME "ARTHREX FIBERSTITCH IMPLANT, CURVED WITH TWO POLYESTER IMPLANTS AND 2-0 FIBERWIRE SUTURE" AR- 4570. LOT 23B129 EXP 2027-08-31. FLUORO CALLED IN THE ROOM, NEEDLE RETRIEVED WITH FLUOR GUIDANCE BY SURGEON. POST OP PORTABLE XRAY DONE. PER DR. (B)(6) (RADIOLOGY) NO NEEDLE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2394577 FIBERSTITCH IMPLANT, CURVED WITH TWO POLYESTER IMPLANTS AND 2-0 FIBERWIRE® SUTU FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI T.A.G. MEDICAL PRODUCTS CORPORATION LTD AR-4570 23B129

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose