BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MENISCAL SUTURE SYSTEM

    MDR report key: 24556006 · Received March 10, 2026

    Report

    Report Number
    3004549189-2026-00006
    Event Type
    Malfunction
    Date Received
    March 10, 2026
    Report Date
    March 10, 2026
    Manufacturer
    S.B.M. SAS
    Product Code
    GAT
    UDI-DI
    03760304680526
    PMA / PMN Number
    K223122
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6), 2025. EVENT DESCRIPTION: "THE PEEK IMPLANTS DID NOT DEPLOY PROPERLY. IN THE FIRST CASE, THE REPAIR APPEARED TO BE WELL FIXED; HOWEVER, WHEN TYING THE KNOT, THE SUTURE BROKE. A SECOND DEVICE WAS USED, BUT THE IMPLANTS FAILED TO PROPERLY DEPLOY BEHIND THE CAPSULE. A THIRD DEVICE WAS THEN USED, AND THE SAME ISSUE OCCURRED. A TOTAL OF THREE DEVICES WERE INVOLVED: TWO UNITS FROM BATCH 254186 AND ONE UNIT FROM BATCH 254178. ALL THREE ISSUES OCCURRED DURING THE SAME SURGERY. THE SURGERY DURATION WAS APPROXIMATELY 40 MINUTES. THE PHYSICIAN CONSIDERED IT A DIFFICULT CASE TO REPAIR. THE JOINT WAS DEFINED AS CHALLENGING DUE TO THE LIMITED WORKING SPACE AND THE COMPLEXITY OF THE LESION. AS THE MENISCAL REPAIR COULD NOT BE SUCCESSFULLY COMPLETED USING SUTURES, THE PROCEDURE WAS FINALIZED WITH A PARTIAL MENISCECTOMY". VERIFICATION OF MANUFACTURING DATA: THE BATCHES CONCERNED COMPLY WITH THE EXPECTED SPECIFICATIONS. INSUFFICIENT INFORMATION: DATE AND LOCATION OF THE INCIDENT NOT PROVIDED; PATIENT IMPACT UNKNOWN. DEVICES ARE NOT AVAILABLE FOR EXPERTISE - INCIDENT REPORT TO BE COMPLETED AND SENT. REQUEST FOR ADDITIONAL INFORMATION TO COMPLETE OUR INVESTIGATION: FIRST DEVICE: CAN YOU DESCRIBE THE EXACT CIRCUMSTANCES (THE REPAIR APPEARED TO BE WELL FIXED; HOWEVER, WHEN TYING THE KNOT, THE SUTURE BROKE)? COULD YOU EXPLAIN? ONCE THE DEVICE WAS PLACED IN THE TISSUE, WAS THERE A FEELING OF DIFFICULTY OR OF RESTRAINT WHEN THE SUTURES WERE PULLED? WHAT IS THE APPROXIMATE LENGTH OF THE REMAINING SUTURE IN THE SURGEON'S HAND AFTER RUPTURE? SECOND AND THIRD DEVICES / "THE IMPLANTS FAILED TO PROPERLY DEPLOY BEHIND THE CAPSULE": WHAT HAPPENED? WHAT DIFFICULTIES DID YOU ENCOUNTER? COULD YOU TELL US WHAT SHAPE THE LESION WAS? WHICH AREA OF THE MENISCUS WAS OPERATED ON? WHAT WAS THE CONDITION OF THE PATIENT'S MENISCUS BEFORE THE PROCEDURE? WHAT PERCENTAGE OF THE INTERVENTION AREA WAS VIABLE? DO YOU HAVE ANY PHOTOS OF THE FAULTY DEVICES?

    Description of Event or Problem · 0

    (B)(4) INCIDENT OCCURED IN ARGENTINA. COMPLAINT DESCRIPTION: EVENT DESCRIPTION: "THE PEEK IMPLANTS DID NOT DEPLOY PROPERLY. IN THE FIRST CASE, THE REPAIR APPEARED TO BE WELL FIXED; HOWEVER, WHEN TYING THE KNOT, THE SUTURE BROKE. A SECOND DEVICE WAS USED, BUT THE IMPLANTS FAILED TO PROPERLY DEPLOY BEHIND THE CAPSULE. A THIRD DEVICE WAS THEN USED, AND THE SAME ISSUE OCCURRED. A TOTAL OF THREE DEVICES WERE INVOLVED: TWO UNITS FROM BATCH 254186 AND ONE UNIT FROM BATCH 254178. ALL THREE ISSUES OCCURRED DURING THE SAME SURGERY. THE SURGERY DURATION WAS APPROXIMATELY 40 MINUTES. THE PHYSICIAN CONSIDERED IT A DIFFICULT CASE TO REPAIR. THE JOINT WAS DEFINED AS CHALLENGING DUE TO THE LIMITED WORKING SPACE AND THE COMPLEXITY OF THE LESION. AS THE MENISCAL REPAIR COULD NOT BE SUCCESSFULLY COMPLETED USING SUTURES, THE PROCEDURE WAS FINALIZED WITH A PARTIAL MENISCECTOMY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620538 MENISCAL SUTURE SYSTEM MENIX® DUO MENISCAL SUTURE SYSTEM WITH TWO ANCHORS GAT S.B.M. SAS 254186 ; 254178 03760304680526

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown Other