BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIBUNION

    MDR report key: 15501702 · Received September 29, 2022

    Report

    Report Number
    3020584246-2022-00046
    Event Type
    Malfunction
    Date Received
    September 29, 2022
    Date of Event
    June 30, 2020
    Report Date
    September 26, 2022
    Manufacturer
    CROSSROADS EXTREMITY SYSTEMS
    Product Code
    HWC
    UDI-DI
    00815432027125
    PMA / PMN Number
    K181872
    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. 3100-0030 501029, MINIBUNION OFFSET PLATE 3.5 STERILE; 280115, 104245, MINIBUNION OFFSET PLATE 3.5; 3100-3022LK, 500729, 3.0 MINIBUNION LOCKING SCREW 22MM STERILE; 3100-3022LK, 103493, 3.0 MINIBUNION LOCKING SCREW 22MM; 3100-2714NL, 501022, 2.7 MINIBUNION NON-LOCKING SCREW 14MM STERILE; 3100-2714NL, 104453, 2.7 MINIBUNION NON-LOCKING SCREW 14MM; 3100-2718NL, 500721, 2.7 MINIBUNION NON-LOCKING SCREW 18MM STERILE; 3100-2718NL, 102678, 2.7 MINIBUNION NON-LOCKING SCREW 18MM.

    Description of Event or Problem · 0

    AT 1-MONTH FOLLOW-UP VISIT, THE X-RAY REVEALED THAT THE SCREW HAD BACKED-OUT. REVISION WAS NOT COMPLETED AS THE PATIENT WAS ASYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2927897 MINIBUNION Screw, fixation, bone HWC CROSSROADS EXTREMITY SYSTEMS 3100-3022LK 500729 00815432027125

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female Other