BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANN PH NAIL RT 9X160MM

    MDR report key: 24274669 · Received February 5, 2026

    Report

    Report Number
    0009613350-2026-00040
    Event Type
    Malfunction
    Date Received
    February 5, 2026
    Date of Event
    November 13, 2025
    Report Date
    February 5, 2026
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSB
    UDI-DI
    00889024505780
    PMA / PMN Number
    K231114
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10. ANN PH NAIL RT 9X160MM ITEM# 47249616009 LOT# 3239977. BLUNT TIP SCREW, ÿ 4X38MM ITEM# 47248603840 LOT# 3245964. BLUNT TIP SCREW, ÿ 4X40MM ITEM# 47248604040 LOT# 3251019. CORTICAL BONE SCREW, ÿ 4X26MM ITEM# 47-2486-126-40 LOT# 3237321R. CORTICAL BONE SCREW, ÿ 4X26MM ITEM# 47248612640 LOT# 3245444. WASHER SMALL (X2) ITEM# 47248800004 LOT# 3238847. PROXIMAL HUMERUS NAIL CAP, 0MM ITEM# 47248801000 LOT# 3241558. G2: FOREIGN - EVENT OCCURRED IN 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 ONE PROXIMAL SCREW BACKED OUT APPROXIMATELY 2 MONTHS POSTOPERATIVELY FOLLOWING AN INTRAMEDULLARY NAILING PROCEDURE. THE PATIENT WAS MONITORED, AND NO REVISION WAS PLANNED. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183479 ANN PH NAIL RT 9X160MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB ZIMMER GMBH 3239977 00889024505780

    Patients

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