BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANN PH NAIL RT 10X220MM

    MDR report key: 24176236 · Received January 26, 2026

    Report

    Report Number
    0009613350-2026-00024
    Event Type
    Injury
    Date Received
    January 26, 2026
    Date of Event
    December 25, 2025
    Report Date
    January 26, 2026
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSB
    PMA / PMN Number
    K231114
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CONCOMITANT MEDICAL PRODUCTS: DESC: ANN BLUNT TIP SCREW 4X40MM; ITEM: 47-2486-040-40; LOT: 3225544. DESC: ANN BLUNT TIP SCREW 4X42MM; ITEM: 47-2486-042-40; LOT: 3237315. DESC: ANN BLUNT TIP SCREW 4X46MM; ITEM: 47-2486-046-40; LOT: 3241530. DESC: ANN CORT BONE SCREW 4 X 28MM; ITEM: 47-2486-128-40; LOT: 3242891. DESC: ANN CORT BONE SCREW 4 X 28MM; ITEM: 47-2486-128-40; LOT: 3242891. DESC: AFFIXUS PH NL CAP 0MM; ITEM: 47-2488-010-00; LOT: 3242900. 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 THE PATIENT UNDERWENT AN INITIAL PROCEDURE WITH AN INTRAMEDULLARY NAIL, AFTER WHICH ONE PROXIMAL SCREW BACKED OUT APPROXIMATELY 2 WEEKS POSTOPERATIVELY. THE PATIENT REMAINED UNDER CLINICAL OBSERVATION AND NO REVISION HAS BEEN PLANNED TO DATE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238686 ANN PH NAIL RT 10X220MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB ZIMMER GMBH 3204819

    Patients

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