BEUDAMED
    FDA Adverse Event Injury Summary report: N

    Z NAIL CMF 5.0X70 ANT SUP SCR

    MDR report key: 23303939 · Received October 15, 2025

    Report

    Report Number
    0009613350-2025-00775
    Event Type
    Injury
    Date Received
    October 15, 2025
    Date of Event
    September 22, 2025
    Report Date
    March 11, 2026
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    UDI-DI
    00889024586727
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, G3, G6, H2, H6, H11. THE REPORTED EVENT COULD NOT BE CONFIRMED DUE TO LACK OF PRODUCT/INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; A PRODUCT EVALUATION COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). D10. 5.0 MM DIAMETER CORTICAL SCREW - RED FIXED ANGLE 3.5 MM HEX HEAD ITEM # 47248402550 LOT # 65891076. 5.0 MM DIAMETER CORTICAL SCREW - RED FIXED ANGLE 3.5 MM HEX HEAD ITEM # 47248402550 LOT # 66126659. Z NAIL CMF 10MMX21.5CM 125 L ITEM# 47249821110 LOT# 3193165. Z NAIL CMF 10.5 X 95 LAG SCR ITEM# 47249909510 LOT# 3178663. Z NAIL CMF NAIL CAP 0MM ITEM# 47250000200 LOT# 3189258. Z NAIL CMF 5.0X70 ANT SUP SCR ITEM# 47250107050 LOT# 3083265. 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 WILL BE SUBMITTED.

    Description of Event or Problem · 0

    DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL OPERATION WITH CMF. THE FRACTURE SITE HAD HEALED, SO THE PATIENT REQUESTED REMOVAL OF THE IMPLANTS. WHEN CONNECTING THE SCREWDRIVER TO THE SCREW, THE DOCTOR APPEARS TO HAVE ACCIDENTALLY PUSHED IT IN. THE PLANNED REMOVAL SURGERY WAS PERFORMED APPROXIMATELY 11 MONTHS POST IMPLANTATION, BUT THE AS SCREW COULD NOT BE REMOVED. CONSEQUENTLY, ONLY THE SCREW REMAINS INSIDE THE PATIENT BODY. 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
    2289268 Z NAIL CMF 5.0X70 ANT SUP SCR IMPLANT, TRAUMA LZO ZIMMER GMBH 3083265 00889024586727

    Patients

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