BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN RFN NAIL SCREW

    MDR report key: 23300241 · Received October 15, 2025

    Report

    Report Number
    0001822565-2025-03730
    Event Type
    Injury
    Date Received
    October 15, 2025
    Date of Event
    October 23, 2017
    Report Date
    December 30, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, NEITHER WERE PROVIDED. COMPLAINT HISTORY REVIEW CANNOT BE PERFORMED WITHOUT PRODUCT IDENTIFICATION. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). E1: ESTABLISHMENT NAME: (B)(6). G2: FOREIGN: UNITED KINGDOM. H3: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL SURGERY APPROXIMATELY 8 YEARS AND 2 MONTHS AGO. SUBSEQUENTLY, APPROXIMATELY 2 MONTHS AND 16 DAYS LATER THE PATIENT DEVELOPED PAIN AND SKIN IRRITATION FROM A PROMINENT SCREW AND UNDERWENT A SECOND SURGERY TO REMOVE THE SCREW. ATTEMPT HAS BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL SURGERY APPROXIMATELY EIGHT (8) YEARS AND TWO (2) MONTHS AGO. SUBSEQUENTLY, APPROXIMATELY ONE (1) MONTH AND THREE WEEKS LATER THE PATIENT DEVELOPED PAIN AND SKIN IRRITATION FROM A PROMINENT SCREW AND UNDERWENT A SECOND SURGERY TO REMOVE THE SCREW. ATTEMPT HAS BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1994034 UNKNOWN RFN NAIL SCREW IMPLANT/TRAUMA HSB ZIMMER BIOMET, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Hospitalization| R