BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIMAX

    MDR report key: 15501549 · Received September 29, 2022

    Report

    Report Number
    3020584246-2022-00044
    Event Type
    Malfunction
    Date Received
    September 29, 2022
    Date of Event
    April 9, 2020
    Report Date
    September 26, 2022
    Manufacturer
    CROSSROADS EXTREMITY SYSTEMS
    Product Code
    JDR
    UDI-DI
    00815432027590
    PMA / PMN Number
    K190722
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE LOT HISTORY RECORDS OF THE STERILE AND INDIVIDUAL COMPONENT PARTS WERE REVIEWED IN THEIR ENTIRETY DURING THE INVESTIGATION. THESE RECORDS INCLUDED QUALITY INSPECTION RECORDS, COMPONENT INSPECTION RECORDS, COMPONENT PRINT SPECIFICATION, COMPONENT SUPPLIER CERTIFICATES OF CONFORMANCE, SUPPLIER INSPECTION CERTIFICATES, RAW MATERIAL CERTIFICATES OF CONFORMANCE, AND SUPPLIER CERTIFICATES OF CONFORMANCE. NO NON-CONFORMANCES WERE FOUND IN ANY RECORDS THAT WERE REVIEWED THAT WOULD HAVE CONTRIBUTED TO THE DEVICE FAILURE. 7318-1818 500917, KEEL-LOCK STAPLE, 240509-EP, 103968, KEEL-LOCK STAPLE - COMPONENT; 7300-1800KT, 104074, KEEL-LOCK STAPLE PREP KIT; 248501, 103573, TRIMAX DRILL GUIDE 18MM; 246002, 103678, INSTRUMENT, DYNAFORCE REAMER.

    Description of Event or Problem · 0

    THE SURGEON PERFORMED AN ISOLATED TN FUSION ON (B)(6) 2020. THE PATIENT WAS FUSED, AND DEVICES WERE INTACT AT 60 DAYS POST-OP. AT 85 DAYS POST-OP, THE X-RAY REVEALS THAT THE KEEL ON THE KEEL-LOCK STAPLE HAS BROKEN AND THE STAPLE HAS BACKED OUT OF THE BONE. THE PATIENT WAS WEIGHT-BEARING IN A CAM BOOT 1 WEEK PRIOR TO OBSERVATION OF THE BROKEN STAPLE. FUSION REMAINS INTACT DESPITE THE BACK-OUT OF THE STAPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2942412 TRIMAX KEEL LOCK JDR CROSSROADS EXTREMITY SYSTEMS 7300-1800KT 104074 00815432027590

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other