BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CROSSROADS SCREW SYSTEM

    MDR report key: 15501539 · Received September 29, 2022

    Report

    Report Number
    3020584246-2022-00028
    Event Type
    Malfunction
    Date Received
    September 29, 2022
    Date of Event
    August 14, 2019
    Report Date
    September 26, 2022
    Manufacturer
    CROSSROADS EXTREMITY SYSTEMS
    Product Code
    HWC
    UDI-DI
    00850310006861
    PMA / PMN Number
    K143039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE LOT HISTORY RECORDS OF THE FOLLOWING STERILE IMPLANTS AND INDIVIDUAL COMPONENT PARTS WERE REVIEWED IN THEIR ENTIRETY DURING THE INVESTIGATION. THESE RECORDS INCLUDE QUALITY INSPECTION PROCEDURES, COMPONENT INSPECTION RECORDS, COMPONENT PRINT SPECIFICATIONS, COMPONENT SUPPLIER CERTIFICATES OF CONFORMANCE, SUPPLIER INSPECTION CERTIFICATES, RAW MATERIAL CERTIFICATES OF CONFORMANCE, AND SUPPLIER CERTIFICATES OF COMPLIANCE. NO NON-CONFORMANCES WERE FOUND IN ANY OF THESE RECORDS THAT WERE REVIEWED. DESCRIPTION, PART NUMBER, LOT NUMBER, 4.0 HEADED IMPLANT PREP KIT INCLUDING REAMER - STERILE, 1456-4040 103145, HEADED BONE SCREW 4.0MM X 26MM - STERILE, 1406-4026 102217, HEADED BONE SCREW 4.0MM X 30MM - STERILE, 1406-4030 102219, HEADED BONE SCREW 4.0MM X 40MM - STERILE, 1406-4040 102224.

    Description of Event or Problem · 0

    REP REPORTS THAT DURING A LAPIDUS PROCEDURE DOCTOR USED 3 SCREWS AND A STAPLE TO PERFORM THE SURGERY. AFTER HE PLACED ONE OF THE 4.0MM SCREWS THE 1.1MM K-WIRE INSTRUMENT BROKE AS HE TRIED TO REMOVE IT FROM THE SCREW. IT HAD TO BE LEFT IN THE PATIENT SINCE IT COULD NOT BE RETRIEVED. REP REPORTS THAT DOCTOR DOES NOT HAVE ANY PLANS TO REVISE THIS PATIENT GOING FORWARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2942402 CROSSROADS SCREW SYSTEM Screw, fixation, bone HWC CROSSROADS EXTREMITY SYSTEMS 1456-4040 103145 00850310006861

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Other