BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DYNAFORCE

    MDR report key: 15502243 · Received September 29, 2022

    Report

    Report Number
    3020584246-2022-00030
    Event Type
    Malfunction
    Date Received
    September 29, 2022
    Report Date
    September 26, 2022
    Manufacturer
    CROSSROADS EXTREMITY SYSTEMS
    Product Code
    JDR
    UDI-DI
    00815432023363
    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 ERE FOUND IN ANY OF THESE RECORDS THAT WERE REVIEWED. DESCRIPTION, PART NUMBER, LOT. NUMBER HIMAXTM 18MM X 18MM X 18MM - STERILE KIT, 7118-1818KT, 500124. HIMAXTM 18MM X 18MM X 18MM - COMPONENT, 240008EP, 102475. HIMAXTM 18MM X 18MM X 18MM - COMPONENT PRE-EP, 240008, 102468. HIMAXTM 18MM X 18MM X 18MM - STERILE PACKED, 7118-1818, 500138. HIMAXTM 18MM X 18MM X 18MM - COMPONENT, 240008, 102529 HIMAXTM 18MM X 18MM X 18MM - COMPONENT PRE-EP, 240008, 102468.

    Description of Event or Problem · 0

    DOCTOR REPORTS THAT ON (B)(6) 2018 HE PERFORMED A 1ST, 2ND, AND 3RD TMT FUSION ON A PATIENT. DOCTOR USED A Z-ALPHA PLATE AND SCREWS WITH A 15MM HIMAX STAPLE FOR THE 1ST TMT FUSION PART OF THE PROCEDURE. FOR THE 2ND AND 3RD TMT FUSION HE USED HIMAX 18MM X 18MM X 18MM STAPLES. HE ALSO USED 2 COMPETITIVE SCREWS TO STABILIZE 1ST RAY OF THE FOOT TO THE 2ND RAY. AT SOME POINT POST-SURGERY, THE HIMAX STAPLES BROKE THAT WERE USED ON THE 2ND TMT AND 3RD TMT FUSIONS. DOCTOR REPORTS THAT THE PATIENT WAS NON-COMPLIANT AND WAS WALKING ON HER FOOT WITHIN THE 1 MONTH AFTER THE OPERATION. HE SAYS THAT THE CT SCAN SHOWS THAT THE 2ND AND 3RD TMT JOINTS STILL EXPERIENCED FUSION EVEN THOUGH THE PATIENT WAS NON-COMPLIANT AND THE STAPLES BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2927935 DYNAFORCE CROSSCLIP JDR CROSSROADS EXTREMITY SYSTEMS 7118-1818KT 500124 00815432023363

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Other