BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANN BLUNT TIP SCREW 4X36MM

    MDR report key: 23568232 · Received November 17, 2025

    Report

    Report Number
    0009613350-2025-00882
    Event Type
    Malfunction
    Date Received
    November 17, 2025
    Date of Event
    November 10, 2025
    Report Date
    April 24, 2026
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSB
    UDI-DI
    00889024505421
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 47-2486-038-40 ANN BLUNT TIP SCREW 4X38MM 3241526; 47-2486-038-40 ANN BLUNT TIP SCREW 4X38MM 3244425; 47-2486-050-40 ANN BLUNT TIP SCREW 4X50MM 3193701; 47-2486-124-40 ANN CORT BONE SCREW 4 X 24MM 3228195; 47-2486-124-40 ANN CORT BONE SCREW 4 X 24MM 3235319; 47-2488-010-00 AFFIXUS PH NL CAP 0MM 3245454; 47-2496-161-09 ANN PH NAIL LT 9X160MM 3239025. G2: REPORT SOURCE: JAPAN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN INITIAL OPERATION WAS PERFORMED WITH ANN NAIL. SUBSEQUENTLY, A PROXIMAL SCREW WAS OBSERVED TO HAVE BACKED OUT APPROXIMATELY 2 WEEKS POSTOPERATIVELY. THE PATIENT WILL BE MONITORED AND NO REVISION SURGERY HAS BE PLANNED SO FAR. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50239 ANN BLUNT TIP SCREW 4X36MM HUMERUS INTRAMEDULLARY NAIL HSB ZIMMER GMBH 3226081 00889024505421

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male