BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DYNAFORCE

    MDR report key: 15501693 · Received September 29, 2022

    Report

    Report Number
    3020584246-2022-00033
    Event Type
    Malfunction
    Date Received
    September 29, 2022
    Report Date
    September 26, 2022
    Manufacturer
    CROSSROADS EXTREMITY SYSTEMS
    Product Code
    JDR
    UDI-DI
    00815432023400
    PMA / PMN Number
    K142727
    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: HIMAX 25MM X 22MM X 22MM - STERILE KIT, PART NUMBER: 7125-2222KT, LOT NUMBER: 300005; HIMAX 25MM X 22MM X 22MM - COMPONENT, 240012EP, 102994; HIMAX 25MM X 22MM X 22MM - STERILE KIT, 7125-2222KT, 500165; HIMAX 25MM X 22MM X 22MM - COMPONENT, 240012EP, 102531; HIMAX 25MM X 22MM X 22MM - COMPONENT, 240012, 102469; HIMAX 25MM X 22MM X 22MM - STERILE KIT, 7125-2222, 500139; HIMAX 25MM X 22MM X 22MM - COMPONENT, 240012EP, 102469; HIMAX 25MM X 22MM X 22MM - COMPONENT, 240012, 102469;

    Description of Event or Problem · 0

    DOCTOR REPORTS THAT ON (B)(6) 2018 HE PERFORMED A MIDFOOT AND SUBTALAR FUSION CASE. HE USED CROSSROADS STAPLES IN THE MIDFOOT TO FUSE THE MEDIAL AND INTERMEDIATE CUNEIFORMS TO A NAVICULAR GRAFT FROM THE ILIAC CREST THAT WAS HARVESTED IN THE SAME SURGERY. THIS PATIENT HAD MUELLER WEISS SYNDROME WHICH IS AN ADULT ONSET OSTEONECROSIS OF THE TARSAL NAVICULAR. AT SOME POINT POST-OPERATION ONE OF THE CLIP LEGS BROKE IN THE PATIENT. DOCTOR SAYS THE BONES EVENTUALLY FUSED EVEN THOUGH ONE OF THE CLIP LEGS WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2926875 DYNAFORCE HIMAX JDR CROSSROADS EXTREMITY SYSTEMS 7125-2222KT 300005 00815432023400

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Other