BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHOENIX ANKLE NAIL CONNECTING BOLT

    MDR report key: 6476229 · Received April 10, 2017

    Report

    Report Number
    0001825034-2017-02397
    Event Type
    Injury
    Date Received
    April 10, 2017
    Date of Event
    February 21, 2017
    Report Date
    June 30, 2017
    Manufacturer
    BIOMET TRAUMA
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). LOT NUMBER FOR THIS PART IS EITHER 852630 OR 301500, HOWEVER IT COULD NOT BE DETERMINED WHICH LOT THIS PART WAS ASSOCIATED WITH. MANUFACTURE DATE - LOT # 852630: FEBRUARY 20, 2013; LOT # 301500: APRIL 22, 2013. THE CONNECTING BOLT WAS RECEIVED FOR EVALUATION AND THE REPORTED EVENT WAS CONFIRMED. A VISUAL REVIEW OF THE RETURNED DEVICE IDENTIFIED THREAD DAMAGE ON THE FIRST THREE THREADS. DIMENSIONAL ANALYSIS AND FUNCTIONAL TESTING WERE NOT CONDUCTED DUE TO THE DAMAGE. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE IDENTIFIED FOR LOTS 852630 OR 301500. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION(S) IS/ARE REQUIRED, AS NO TRENDS WERE IDENTIFIED. THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANKLE FUSION PROCEDURE, THE NAIL WAS ATTACHED TO THE JIG AND A STATIC SCREW WAS PLACED IN THE ANKLE NAIL. SUBSEQUENTLY, COMPRESSION WAS APPLIED TO THE NAIL AND JIG AND THE NAIL SLIPPED OFF OF THE CONNECTING BOLT, CAUSING THE BOLT TO BE CHIPPED AND DEFORMED. THERE WAS A SIXTY (60) MINUTE DELAY IN THE PROCEDURE TO REPLACE WITH A NEW NAIL. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259033 PHOENIX ANKLE NAIL CONNECTING BOLT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH BIOMET TRAUMA N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R