BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHOENIX CONNECTING BOLT

    MDR report key: 7658366 · Received July 3, 2018

    Report

    Report Number
    0001825034-2018-04342
    Event Type
    Malfunction
    Date Received
    July 3, 2018
    Date of Event
    May 25, 2018
    Report Date
    November 2, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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. PRODUCT NOT RETURNED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS - CARBON TARGET ARM - ANKLE NAIL, CAT#: 14-440050 LOT#: NI, ANKLE LOCKING NAIL 10 X 150MM, CAT#: 14-440115 LOT#: 663820, TI-DBLE LEAD CORT 5.0X24MM SCR, CAT#: 14-405024 LOT#: 153610 (QTY 2), TI-DBLE LEAD CORT 5.0X85MM SCR, CAT#: 14-405085 LOT#: 819560, TI-DBLE LEAD CORT 5.0X36MM SCR, CAT#: 14-405036 LOT#: 671540, TI-DBLE LEAD CORT 5.0X70MM SCR, CAT#: 14-405070 LOT#: 425830, TI-DBLE LEAD CORT 5.0X36MM SCR, CAT#: 14-405036 LOT#: 680900. REPORT SOURCE, FOREIGN ¿ EVENTS OCCURRED IN (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

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CONNECTING BOLT WOULD NOT ASSEMBLE TO THE NAIL EASILY DURING AN ANKLE NAIL ORIF. ANOTHER CONNECTING BOLT WAS USED WITHOUT INCIDENCE TO COMPLETE THE PROCEDURE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503775 PHOENIX CONNECTING BOLT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1