BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECTING ROD HOFFMANN II MICRO Ø 3 X 50MM

    MDR report key: 25317488 · Received May 28, 2026

    Report

    Report Number
    0008031020-2026-00720
    Event Type
    Malfunction
    Date Received
    May 28, 2026
    Date of Event
    October 21, 2025
    Report Date
    May 28, 2026
    Manufacturer
    STRYKER GMBH
    Product Code
    KTT
    UDI-DI
    04546540389916
    PMA / PMN Number
    K033476
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT COULD BE CONFIRMED, SINCE THE PRODUCT WAS RETURNED FOR EVALUATION AND MATCHES THE ALLEGED FAILURE. THE DEVICE INSPECTION REVEALED THE FOLLOWING: VISUAL EXAMINATION OF THE RECEIVED PRODUCT SHOWS THAT BOTH ENDS HAVE FINE CRACKS, AS REPORTED. OTHERWISE, THE PART IS IN A GOOD AND NOT DAMAGED CONDITION. INSPECTION OF THE RECEIVED INFORMATION/EVIDENCE ARE DONE OR WILL BE DONE, IN THE PROCEEDINGS OF THE NC. BASED ON INVESTIGATION, THE ROOT CAUSE WAS ATTRIBUTED TO A DESIGN RELATED ISSUE.

    Description of Event or Problem · 0

    AS REPORTED: "UPON DOING INSPECTIONS FOR PQH 4135808, CRACKS WERE FOUND ON THE ENDS OF ADDITIONAL RODS NOT WITHIN THE SCOPE OF THE PRODUCT HOLD.".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232087 CONNECTING ROD HOFFMANN II MICRO Ø 3 X 50MM APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT KTT STRYKER GMBH V11170 04546540389916

    Patients

    Seq Age Sex Outcome Treatment
    1