BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOOK MCO805 165MM 2.0MM 90DEG BLUNT

    MDR report key: 21521245 · Received March 4, 2025

    Report

    Report Number
    3003249645-2025-00007
    Event Type
    Malfunction
    Date Received
    March 4, 2025
    Date of Event
    January 29, 2025
    Report Date
    March 4, 2025
    Manufacturer
    INTEGRA MICROFRANCE S.A.S.
    Product Code
    JYL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE 165MM 2.0MM 90DEG BLUNT HOOK (MCO805) WAS NOT RETURNED TO THE MANUFACTURER. LOT NUMBER INFORMATION WAS NOT PROVIDED; THUS, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. IT WAS NOTED THAT IF THE END OF THE HOOK BROKE DURING THE INTERVENTION, IT IS PROBABLY THAT IT HAD BEEN WEAKENED BY AN IMPACT DURING CLEANING OR BY A FALL. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "IN THE ENT AND HEAD AND NECK SURGERY OPERATING ROOM, DURING A MENINGEAL PLASTY FOR EXCISION SURGERY OF A LEFT ETHMOID ADENOCARCINOMA, BREAKAGE OF THE END OF THE STAINLESS-STEEL BUTTONED HOOK"/165MM 2.0MM 90DEG BLUNT HOOK (MCO805) OCCURRED. "THE INSTRUMENT BELONGS TO THE OPERATING TRAY CALLED 'MENINGEAL TRAY'." IT WAS REPORTED THAT "THE SIZE OF THE BROKEN PART WAS ESTIMATED AT 2MM. THE FRAGMENT WAS NOT FOUND IN THE OPERATING FIELD. THE PATIENT WAS SUBJECTED TO CLINICAL MONITORING AND A CT (COMPUTED TOMOGRAPHY) SCAN THAT DID NOT REVEAL THE PRESENCE OF THE BROKEN ELEMENT." THERE WERE REPORTEDLY NO OTHER CLINICAL CONSEQUENCES FOR THE PATIENT NOR EXTENSION OF PROCEDURE TIME. THE INSTRUMENT WAS DISCARDED AND REPLACED IN THE OPERATING TRAY AFTER THE OPERATION. IT WAS REPORTED THAT THIS WAS AN ISOLATED INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2275377 HOOK MCO805 165MM 2.0MM 90DEG BLUNT PFM11 JYL INTEGRA MICROFRANCE S.A.S. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown