BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARBON TARGET ARM - ANKLE NAIL

    MDR report key: 7369078 · Received March 26, 2018

    Report

    Report Number
    0001825034-2018-02168
    Event Type
    Injury
    Date Received
    March 26, 2018
    Date of Event
    February 26, 2018
    Report Date
    November 14, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LXH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    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 NOT CONFIRMED. AS RETURNED THE DEVICES WERE VISUALLY REVIEWED. THE TARGETING JIG EXHIBITS LITTLE TO NO DAMAGE AND APPEARS VISUALLY CONFORMING TO PRINT. THE CONNECTING BOLTS ALSO HAVE LITTLE TO NO VISUAL DAMAGE. THERE IS SLIGHT STAINING AROUND THE ETCH. THE TARGETING JIG WAS FUNCTIONALLY CHECKED AGAINST INSPECTION CRITERIA AND WAS FOUND TO BE CONFORMING TO SPECIFICATIONS. ONE OF THE CONNECTING BOLTS, LOT PU79A, WAS DIMENSIONALLY INSPECTED AND FOUND TO BE CONFORMING. THE SECOND CONNECTING BOLT, LOT PU21A, HAD DAMAGE TO THE THREADS MAKING DIMENSIONAL ANALYSIS NOT POSSIBLE. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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). DATE OF BIRTH: 1972. CONCOMITANT MEDICAL PRODUCTS: 14-440042, CONNECTING BOLT, UNKNOWN, 14-440115, ANKLE LOCKING NAIL 10 X 150MM, 791360, 14-440042, CONNECTING BOLT, UNKNOWN, 14-440053, DRIVER HANDLE- SLAP HAMMER END, UNKNOWN. REPORT SOURCE, FOREIGN - THE EVENT 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 02169, 0001825034 - 2018 - 02170.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NAIL AND GUIDE MISALIGNED CAUSING THE NEED TO RE-DRILL AND THE NEED TO MOVE THE PATIENT'S BONE WHICH CAUSED MORBIDITY AND BLEEDING TO THE ANTERIOR TISSUE OF THE LOWER LEG. THERE WAS ALSO A SURGICAL DELAY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213500 CARBON TARGET ARM - ANKLE NAIL SURGICAL, INSTRUMENT LXH ZIMMER BIOMET, INC. N/A 55238

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R