BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHOENIX ANKLE NAIL SYSTEM TARGETING ARM

    MDR report key: 7176720 · Received January 9, 2018

    Report

    Report Number
    0001825034-2018-00067
    Event Type
    Malfunction
    Date Received
    January 9, 2018
    Date of Event
    December 18, 2017
    Report Date
    December 26, 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
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURE DATES: FEB 24, 2015 FOR LOT 098770, MAR 23, 2015 FOR LOT 551510, AUG 13, 2014 FOR LOT 983770. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. VISUAL INSPECTION UPON RECEIPT IS CONFORMING TO THE PRINT. THE INSTRUMENT IS 4 YEARS OLD AND HAS NO NICKS, DINGS OR GOUGES EXCEPT ONE AND IT DOES NOT INVOLVE ANY OF THE HOLES. THE COMPLAINT IS FOR THE DISTAL HOLES NOT ALIGNING WITH THE NAIL. ALL 7 HOLES WERE CHECK FOR SIZE WITH GAGE PINS AND ARE CONFORMING. THE LOCATION OF THE HOLES WAS CHECKED ON THE COMPARATOR AND ARE CONFORMING. THE TRANSACTION HISTORY FOR THIS PART SHOWS THAT THE LOT WAS ISSUED TO 3 WORK ORDERS; 098770, 551510 & 983770; THEREFORE ALL THREE WERE REVIEWED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO 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

    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 · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). (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 THE PATIENT UNDERWENT AN ANKLE ARTHRODESIS PROCEDURE. DURING THE PROCEDURE, THE SURGEON EXPERIENCED ISSUES WHILE ATTEMPTING TO DRILL THE PROXIMAL SCREWS WITH THE DRILL HITTING THE NAIL. IT WAS DISCOVERED THAT THE JIG FOR THE ANKLE NAIL HAD COME OUT OF ALIGNMENT. PRIOR TO DRILLING, THE JIG HAD BEEN LOADED CORRECTLY AND ALL OF THE SCREW HOLES WERE ALIGNED WITH THE TROCAR. THE MISALIGNMENT WAS OBSERVED WHILE THE NAIL WAS BEING IMPLANTED. PROXIMAL LOCKING WAS THEN ACHIEVED FREEHAND, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. NO PATIENT IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18167 PHOENIX ANKLE NAIL SYSTEM TARGETING ARM ROD, FIXATION LXH ZIMMER BIOMET, INC. N/A ZBCRUK1610

    Patients

    Seq Age Sex Outcome Treatment
    1