BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILVERBACK, INSTRUMENT CADDY

    MDR report key: 12471836 · Received September 14, 2021

    Report

    Report Number
    3008650117-2021-00107
    Event Type
    Malfunction
    Date Received
    September 14, 2021
    Date of Event
    August 20, 2021
    Report Date
    September 14, 2021
    Manufacturer
    PARAGON 28, INC
    Product Code
    FSM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    GSBINS IS A KIT MADE UP OF A BASE (PART NUMBER P50-900-1001), LID (PART NUMBER P50-900-3001), AND TRAYS (PART NUMBERS P50-900-1003 & P50-900-1006). CONTENTS INCLUDE INSTRUMENTS AND OR IMPLANTS REQUIRED FOR A PARTICULAR SYSTEM. ONCE ASSEMBLED, KITS GET ASSIGNED A SERIAL IDENTIFICATION NUMBER VERSUS A PART NUMBER. THE GSBINS KITS REQUIRE A CERTAIN NUMBER OF DRIVERS IN EACH KIT; 2 EACH HX10 DRIVERS. IT WAS DISCOVERED INTRAOPERATIVELY THAT THIS KIT CONTAINED ONLY A QUANTITY OF ONE HX10 DRIVER. THIS RESULTED IN A DELAY OF OVER 30 MINUTES TO THE SURGERY. IF FURTHER INFORMATION IS IDENTIFIED WHICH ALTERS THIS EVENT'S CONCLUSION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 1

    KIT GSBINS WAS MISSING AN HX-10 SCREW DRIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1369451 SILVERBACK, INSTRUMENT CADDY SILVERBACK, INSTRUMENT CADDY FSM PARAGON 28, INC GSBINS

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR