BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MENIX

    MDR report key: 18311048 · Received December 12, 2023

    Report

    Report Number
    3004549189-2023-00005
    Event Type
    Malfunction
    Date Received
    December 12, 2023
    Date of Event
    November 27, 2023
    Report Date
    September 10, 2024
    Manufacturer
    S.B.M. SAS
    Product Code
    GAT
    PMA / PMN Number
    K223122
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). 2023 USE OF ANOTHER COMPETING MEDICAL DEVICE - NO OTHER COMPLAINT CONCERNING THIS BATCH NUMBER - NO INCIDENT DURING MANUFACTURING. WAITING FOR ADDITIONAL INFORMATION TO COMPLETE OUR INVESTIGATION. INSUFFICIENT INFORMATION / ANALYSIS IS ONGOING.

    Additional Manufacturer Narrative · 0

    (B)(6), 2023. USE OF ANOTHER COMPETING MEDICAL DEVICE - NO OTHER COMPLAINT CONCERNING THIS BATCH NUMBER - NO INCIDENT DURING MANUFACTURING. WAITING FOR ADDITIONAL INFORMATION TO COMPLETE OUR INVESTIGATION. INSUFFICIENT INFORMATION / ANALYSIS IS ONGOING. (B)(6), 2024. ADDITIONAL INFORMATION: "ABOUT THE MENIX DEVICE, DURING THE IMPLANTATION THERE NO DIFFICULTY. THE IMPLANTS WAS PLACED CORRECTLY AND THE SUTURES SLIDE FREELY. IN THE MOMENT OF TIGHTENING THE SUTURES THE SUTURES BROKE AND STAY IN THE HANDS. THE TWO IMPLANTS STAY ON THE MENISCUS AND THIS HAPPENED AGAIN WITH THE OTHER DEVICE. THE SURGEON WAS TRAINED IN A PLASTIC MENISCUS TWICE. IN THE TRAINING THERE WASN'T ANY FAILURE OF THE DEVICE. ALL THE IMPLANTS STAY INSIDE THE PATIENT THAT MEAN WAS 4 OF THEM". RESULT OF INVESTIGATIONS: THE PRODUCTION OF BATCH 232406 COMPLIES WITH THE PRODUCTION SPECIFICATIONS. MEDICAL DEVICES NOT EXPLANTED (THE PATIENT HAS KEPT ONE OR MORE PIECES) / NO RECOVERY OF THE DEVICES: NO DIRECT ANALYSIS POSSIBLE TO IDENTIFY THE CAUSE OF THE BREAKAGE / NO PHOTOS. THE INVESTIGATION FINDINGS DO NOT LEAD TO A CLEAR CONCLUSION ABOUT THE CAUSE OF THIS EVENT (LACK OF INFORMATION AND THE DEVICES WERE NOT AVAILABLE FOR EXPERTISE). NOTE: THE SURGEON WAS NOT YET FAMILIAR WITH THE MEDICAL DEVICE AT THE TIME OF THIS OPERATION (FIRST-TIME USE). HYPOTHESIS NO. 1: NEEDLES THAT MAY BE TOO SHARP. HYPOTHESIS NO. 2: LACK OF HABIT OF THE USERS. NO OTHER COMPLAINT CONCERNING THIS LOT - CAUSE NOT CLEARLY ESTABLISHED - NO ACTION IMPLEMENTED. THE SURGEON NEEDS TIME TO FAMILIARIZE HIMSELF WITH THE SYSTEM OF MEDICAL DEVICE.

    Description of Event or Problem · 0

    (B)(4). INCIDENT OCCURED IN GREECE: EVENT DESCRIPTION COMMUNICATED. "MENIX DUO WAS PLACED IN THE RIGHT WAY TO THE MENISCUS BUT WHEN HE START TIGHT THE KNOT, AT THIS TIME THE SUTURE BROKE. THIS HAPPENED AGAIN WITH ANOTHER MENIX DUO DEVICE EXACTLY WITH THE SAME CIRCUMSTANCES". INCIDENT REPORT: NO CLINICAL CONSEQUENCES - SURGICAL TIME INCREASED OVER THAN 30MN RELATED TO THE EVENT - THE PATIENT HAS KEPT ONE OR MORE PIECES OF THE DEVICE.

    Description of Event or Problem · 0

    (B)(4). INCIDENT OCCURED IN GREECE: EVENT DESCRIPTION COMMUNICATED. "MENIX DUO WAS PLACED IN THE RIGHT WAY TO THE MENISCUS BUT WHEN HE START TIGHT THE KNOT, AT THIS TIME THE SUTURE BROKE. THIS HAPPENED AGAIN WITH ANOTHER MENIX DUO DEVICE EXACTLY WITH THE SAME CIRCUMSTANCES". INCIDENT REPORT: NO CLINICAL CONSEQUENCES - SURGICAL TIME INCREASED OVER THAN 30MN RELATED TO THE EVENT - THE PATIENT HAS KEPT ONE OR MORE PIECES OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1580845 MENIX MENIX® DUO MENISCAL SUTURE SYSTEM, 2 ANCHORS GAT S.B.M. SAS 232406

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Female Other