BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MENIX

    MDR report key: 19837933 · Received July 26, 2024

    Report

    Report Number
    3004549189-2024-00003
    Event Type
    Malfunction
    Date Received
    July 26, 2024
    Date of Event
    July 19, 2024
    Report Date
    July 26, 2024
    Manufacturer
    S.B.M. SAS
    Product Code
    GAT
    PMA / PMN Number
    K223122
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    26 JULY 2024 NO OTHER COMPLAINT CONCERNING THIS BATCH NUMBER - NO INCIDENT DURING MANUFACTURING. REQUEST FOR FURTHER INFORMATION ON THE CIRCUMSTANCES OF THE INCIDENT AND THE POTENTIAL CLINICAL CONSEQUENCES FOR THE PATIENT: AWAITING RETRIEVAL OF AN INCIDENT REPORT. PINS LOT 230568 ISOLATED FOR VERIFICATION - RECOVERY OF A MEDICAL DEVICE WITH BROKEN PIN FOR EXPERTISE + 3 MENIX DUO BOXES FROM THE SAME LOT 241187 ISOLATED FOR TESTING AND VERIFICATION. INSUFFICIENT INFORMATION / ANALYSIS IS ONGOING.

    Description of Event or Problem · 0

    FNCONF-24-0140 INCIDENT OCCURED IN FRANCE: EVENT DESCRIPTION COMMUNICATED. "3 INTRAOPERATIVE RUPTURES OF MENIX PINS LOT 241187 ON (B)(6) 2024." NO PATIENT CONSEQUENCES REPORTED - NO INFORMATION CONCERNING THE CIRCUMSTANCES OF THE INCIDENT. THE PATIENT'S AGE NEEDS TO BE CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1705591 MENIX MENIX® DUO MENISCAL SUTURE SYSTEM, 2 ANCHORS GAT S.B.M. SAS 241187

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Unknown Other