BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OFFSET END CAP 11X10MM .433D OFFSET

    MDR report key: 12696591 · Received October 26, 2021

    Report

    Report Number
    0001825034-2021-02946
    Event Type
    Malfunction
    Date Received
    October 26, 2021
    Date of Event
    September 26, 2021
    Report Date
    November 17, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSB
    PMA / PMN Number
    K091976
    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. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: DISPLACEMENT OF THE NAIL END CAP AT THE CALCANEUS. NO FRACTURE OR OTHER ABNORMALITY IS NOTED AND ALIGNMENT IS MAINTAINED. A SMALL AMOUNT OF RADIOLUCENCY IS NOTED ALONG THE DISTAL NAIL AND END CAP. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. 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.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE FOREIGN: (B)(6). CONCOMITANT MEDICAL PRODUCTS: ANKLE LOCKING NAIL 12 X 210MM CAT: 14-440321 LOT: 028130. TI-DBLE LEAD CORT 5.0X28MM SCR CAT: 14-405028 LOT: 101720. TI-DBLE LEAD CORT 5.0X28MM SCR CAT: 14-405028 LOT: 907050. TI-DBLE LEAD CORT 5.0X46MM SCR CAT: 14-405046 LOT: 916480. TI-DBLE LEAD CORT 5.0X75MM SCR CAT: 14-405075 LOT: 729800R. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT ANKLE PROCEDURE. SUBSEQUENTLY, THE IMPLANTS DISASSEMBLED. NO REVISION PROCEDURE HAS BEEN INDICATED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1596272 OFFSET END CAP 11X10MM .433D OFFSET ROD, FIXATION HSB ZIMMER BIOMET, INC. 773890R

    Patients

    Seq Age Sex Outcome Treatment
    1 Male SEE H10