BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FFB BL CO-BR 2 HC-5 1N 38" STRYKER

    MDR report key: 16569442 · Received March 18, 2023

    Report

    Report Number
    3004365956-2023-00017
    Event Type
    Malfunction
    Date Received
    March 18, 2023
    Date of Event
    November 28, 2022
    Report Date
    February 22, 2023
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GAT
    UDI-DI
    04026704603398
    PMA / PMN Number
    K063778
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). NO ISSUES OR DISCREPANCIES WERE FOUND IN THE DEVICE HISTORY RECORD OF PRODUCT CODE 3910-900-020 / BATCH 74E2202667 THAT CAN BE RELATED TO THE FAILURE MODE REPORTED. CUSTOMER COMPLAINT CANNOT BE CONFIRMED BASED ONLY ON THE INFORMATION PROVIDED, TO PERFORM AN INVESTIGATION AND DETERMINE THE SOURCE OF DEFECT REPORTED IT IS NECESSARY TO EVALUATE THE SAMPLE INVOLVED ON THIS COMPLAINT. AN ATTEMPT TO DUPLICATE THE FAILURE MODE WAS MADE BUT AT THE TIME THERE IS NO INVENTORY OF THE INVOLVED PRODUCT CODE AVAILABLE AT THE FACILITY IS NOT BEING MANUFACTURED AT THE TIME. IF THE SAMPLE BECOMES AVAILABLE THIS INVESTIGATION WILL BE UPDATED WITH THE EVALUATION RESULTS.

    Description of Event or Problem · 0

    REPORTED ISSUE: SUTURE BURST WITH TRACTION CAUSING PROBLEM IN SURGERY. ADDITIONAL INFORMATION: THE DISTRIBUTOR STATED THAT THE PROCEDURE WAS DELAYED AND ULTIMATELY THE PATIENT'S PATHOLOGY COULD NOT BE COMPLETELY RESOLVED. A RECONSTRUCTION OF THE ANTERIOR CRUCIATE LIGAMENT AND SUTURE OF THE MENISCAL ROOT WAS BEING PERFORMED BY ARTHROSCOPY. THE DELAY WAS BECAUSE AN ATTEMPT WAS MADE TO SEEK AUTHORIZATION FROM THE HEALTH AUTHORITY TO USE THE MATERIAL OF ANOTHER MANUFACTURER. THE PATIENT WAS UNDER SPINAL ANESTHESIA THROUGHOUT THE ENTIRE PROCEDURE. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1009893 FFB BL CO-BR 2 HC-5 1N 38" STRYKER SUTURE, NONABSORBABLE, SYNTHE GAT TELEFLEX MEDICAL IPN000852 74E2202667 04026704603398

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown NONE REPORTED