BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EB EXC GRN 4X30IN 2 S/A V-37

    MDR report key: 18661782 · Received February 7, 2024

    Report

    Report Number
    2210968-2024-01099
    Event Type
    Malfunction
    Date Received
    February 7, 2024
    Date of Event
    January 3, 2024
    Report Date
    February 7, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    UDI-DI
    10705031047150
    PMA / PMN Number
    K946173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). H6 COMPONENT CODE: G07002 - DEVICE NOT RETURNED THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED VIA: THEY DID NOT SAVE THE LOT NUMBER INFO. THE PERSON PROVIDING INFORMATION IS NICOLE GEE. SHE IS THE ORTHO COORDINATOR. THANK YOU THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, A MANUFACTURING RECORD EVALUATION COULD NOT BE PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SALES REP REPORTED THAT THE SUTURE WAS POPPING OFF THE NEEDLE WHEN TRYING TO DO CLOSURE ON A PATIENT. NO PATIENT HARM AND THE TOTAL KNEE REPLACEMENT WAS COMPLETED WITH ANOTHER SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1907750 EB EXC GRN 4X30IN 2 S/A V-37 SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC. 10705031047150

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown