BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Z NAIL CMF 10.5 X 95 LAG SCR

    MDR report key: 24718392 · Received March 30, 2026

    Report

    Report Number
    0009613350-2026-00192
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    March 5, 2026
    Report Date
    March 27, 2026
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSB
    UDI-DI
    00889024586581
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10. Z NAIL CMF 9.3 MM X 17.5 CM 125L, ITEM# 47249818109 LOT# 3218040. Z NAIL CMF 5.0 X 75 ANT SUP SCR, ITEM# 47250107550 LOT# 3228774. 5.0 MM DIAMETER CORTICAL SCREW - RED FIXED ANGLE 3.5 MM HEX HEAD, ITEM# 47248403050 LOT# 67162645. 5.0 MM DIAMETER CORTICAL SCREW - RED FIXED ANGLE 3.5 MM HEX HEAD ITEM# 47248403050 LOT# 67175042. Z NAIL CMF NAIL CAP 0 MM, ITEM# 47250000200, LOT# 3250454. 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 LAG SCREW OF AN INTRAMEDULLARY NAIL CONSTRUCT WAS OBSERVED ON RADIOGRAPHS TO BE SLIDING TOWARD THE OUTER SIDE APPROXIMATELY THREE MONTHS POST-IMPLANTATION. THE PATIENT REMAINED UNDER CLINICAL MONITORING, AND NO REVISION WAS PLANNED AT THE TIME OF THE REPORT. 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
    781424 Z NAIL CMF 10.5 X 95 LAG SCR IMPLANT, TRAUMA HSB ZIMMER GMBH 3230574 00889024586581

    Patients

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