BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANN PH NAIL LT 9X160MM

    MDR report key: 23568229 · Received November 17, 2025

    Report

    Report Number
    0009613350-2025-00881
    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
    00889024505810
    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: 47-2486-036-40; ANN BLUNT TIP SCREW 4X36MM; (B)(6). 47-2486-038-40; ANN BLUNT TIP SCREW 4X38MM; (B)(6). 47-2486-038-40; ANN BLUNT TIP SCREW 4X38MM; (B)(6). 47-2486-050-40; ANN BLUNT TIP SCREW 4X50MM; (B)(6). 47-2486-124-40; ANN CORT BONE SCREW 4 X 24MM; (B)(6). 47-2486-124-40; ANN CORT BONE SCREW 4 X 24MM; (B)(6). 47-2488-010-00; AFFIXUS PH NL CAP 0MM; (B)(6). 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
    259482 ANN PH NAIL LT 9X160MM HUMERUS INTRAMEDULLARY NAIL HSB ZIMMER GMBH 3239025 00889024505810

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male SEE H11 NARRATIVE.