BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PICCOLO COMPOSITE PROXIMAL HUMERUS PLATE

    MDR report key: 10024868 · Received May 5, 2020

    Report

    Report Number
    9615128-2020-00004
    Event Type
    Malfunction
    Date Received
    May 5, 2020
    Date of Event
    March 18, 2020
    Report Date
    May 5, 2020
    Manufacturer
    CARBOFIX ORTHOPEDICS LTD.
    Product Code
    HRS
    PMA / PMN Number
    K102597
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVOLVED PLATE, WITHIN ITS DOUBLE-POUCH PACK, WAS RECEIVED AT THE COMPANY AND INSPECTED. BASED ON THE EXAMINATION, THE IMPLANT WAS FOUND TO BE IN ORDER, WITH SMOOTH DISTAL TIP (NO SHARP EDGES). THE DISTAL END OF THE PLATE SEEMED TO SLIGHTLY PENETRATE THE INTERNAL POUCH SEALING. EXAMINATION OF THE PRODUCTION RECORDS OF THE INVOLVED PLATE AND ITS PACKAGING DID NOT REVEAL DEVIATION FROM SPECIFICATION. IMPORTANTLY, THE SEALING MACHINE USED TO SEAL THE POUCHES IS VALIDATED IN THE BEGINNING OF EACH WORKING DAY BY PERFORMING SEAL STRENGTH TEST AND SEAL INTEGRITY TEST. ADDITIONALLY, EACH POUCH IS VISUALLY EXAMINED FOR SEALING INTEGRITY FOLLOWING THE SEALING PROCESS. SPECIFICALLY, THE RECORDS INDICATE THAT THE TESTS CONDUCTED AT THE DAY THE INVOLVED PRODUCT WAS PACKED MET THE TESTS ACCEPTANCE CRITERIA. NOTE: DUE TO RESTRICTIONS RELATED TO THE CORONAVIRUS SITUATION, THE SUBMISSION OF THIS REPORT WAS DELAYED.

    Description of Event or Problem · 1

    DURING OPERATION IN (B)(6), UPON OPENING THE PACKAGING OF THE PLATE, IT WAS NOTED THAT THE POUCH SEALING WAS COMPROMISED. ANOTHER PLATE WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488102 PICCOLO COMPOSITE PROXIMAL HUMERUS PLATE BONE PLATE HRS CARBOFIX ORTHOPEDICS LTD. 91638

    Patients

    Seq Age Sex Outcome Treatment
    1