BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AEQUALIS FRACTURE NM BONE GRAFT CUTTING DEVICE

    MDR report key: 19929367 · Received August 7, 2024

    Report

    Report Number
    3000931034-2024-00426
    Event Type
    Malfunction
    Date Received
    August 7, 2024
    Date of Event
    August 29, 2023
    Report Date
    December 16, 2024
    Manufacturer
    TORNIER S.A.S.
    Product Code
    HXD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: PLEASE REFER H6 (RESULT CODE AND CONCLUSION CODE AND HEALTH CODE), D5 OPERATOR OF DEVICE. THE REPORTED EVENT COULD BE CONFIRMED, SINCE EVIDENCES WERE PROVIDED FOR INVESTIGATION. THE PICTURE PROVIDED BY THE COMPLAINT REPORTER SHOWS THAT RESIDUES FROM THE PREVIOUS SURGERY. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. AS PER THE INSTRUCTION FOR USE, IT IS NOTED THAT MULTICOMPONENT INSTRUMENTS MUST BE DISASSEMBLED FOR CLEANING. THE EVENT WAS CAUSED BY A NON-DISASSEMBLY OF THE BONE GRAFT CUTTING DEVICE. A REVIEW OF THE DEVICE HISTORY WAS NOT POSSIBLE BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. INDICATIONS OF MATERIAL, MANUFACTURING, OR DESIGN RELATED PROBLEMS WERE UNABLE TO BE IDENTIFIED AS THE LOT NUMBER WAS NOT COMMUNICATED. IF THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.

    Additional Manufacturer Narrative · 0

    BASED ON THE AVAILABLE INFORMATION THE DEVICE WILL NOT BE RETURNED THEREFORE AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY IS NOT POSSIBLE BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    CUSTOMER COMPLAINT ABOUT THE CLEANABILITY OF PRODUCT.

    Description of Event or Problem · 0

    CUSTOMER COMPLAINT ABOUT THE CLEANABILITY OF PRODUCT .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220539 AEQUALIS FRACTURE NM BONE GRAFT CUTTING DEVICE CLAMP HXD TORNIER S.A.S. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown