BEUDAMED
    FDA Adverse Event Injury Summary report: N

    Z NAIL CMF 10.5 X 95LAG SCR

    MDR report key: 15011396 · Received July 14, 2022

    Report

    Report Number
    0009613350-2022-00367
    Event Type
    Injury
    Date Received
    July 14, 2022
    Date of Event
    June 13, 2022
    Report Date
    August 22, 2022
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    HSB
    UDI-DI
    00889024586581
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    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). MEDICAL DEVICES: Z NAIL CMF11.5MMX17.5CM 125R, ITEM# 47249818011; LOT# 3069008. Z NAIL CMF NAIL CAP 0MM; LOT# 47250000200;ITEM# 3091641. 5.0 MM DIAMETER CORTICALSCREW - RED FIXED ANGLE 3.5MM HEX HEAD; ITEM# 47248403050; LOT# 65225701. Z NAIL CMF 5.0X75 ANT SUPSCR; ITEM# 47250107550; LOT# 3075481. REPORT SOURCE: FOREIGN: JAPAN. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0009613350 - 2022 - 00368. 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. AS NO PRODUCT WAS RETURNED, VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. DEVICES ARE USED FOR TREATMENT. MEDICAL RECORDS WERE NOT PROVIDED. THE INVESTIGATION DID NOT IDENTIFY A NON-CONFORMANCE OR A COMPLAINT OUT OF BOX (COOB). THERE ARE NO RECALLS OR PRODUCT HOLDS FOR THE REPORTED PRODUCTS. BASED ON THE AVAILABLE INFORMATION IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE FOR THIS ISSUE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED, THAT TWO WEEKS AFTER THE INITIAL OPERATION THE LAG SCREW WAS SLIDING TO OUTER THE SIDE. REVISION IS NOT PLANNED, THE PATIENT'S CONDITION WILL BE CONTINUED TO BE MONITORED. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2349853 Z NAIL CMF 10.5 X 95LAG SCR TRAUMA PROSTHESIS HSB ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 3079068 00889024586581

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other SEE H10 NARRATIVE.