BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    K-WIRE SS 1.6X127MM .062 ST

    MDR report key: 8663956 · Received June 3, 2019

    Report

    Report Number
    0001825034-2019-02379
    Event Type
    Malfunction
    Date Received
    June 3, 2019
    Date of Event
    May 14, 2019
    Report Date
    September 27, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HXC
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL EVALUATION OF THE RETURNED PRODUCT IDENTIFIED THAT THERE IS HAIR-LIKE DEBRIS INSIDE THE STERILE PACKAGE. FTIR ANALYSIS CONDUCTED ON THE FOREIGN MATERIAL IN THE PACKAGE IDENTIFIED THAT IT IS CONSISTENT WITH THE FTIR SPECTRA OF BIOLOGICAL MATERIAL (LIKELY A HAIR). DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE PRODUCT WAS LIKELY NON-CONFORMING WHEN IT LEFT ZIMMER BIOMET CONTROL. THE ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO THE OPERATOR NOT FOLLOWING INSTRUCTIONS DURING MANUFACTURING. 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.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INSPECTION, HAIR LIKE DEBRIS WAS FOUND IN THE STERILE PACKAGE. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456415 K-WIRE SS 1.6X127MM .062 ST PROSTHESIS, TRAUMA HXC ZIMMER BIOMET, INC. N/A 008710

    Patients

    Seq Age Sex Outcome Treatment
    1