BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL NAIL RETRO 12MM X 380MM

    MDR report key: 4766450 · Received May 12, 2015

    Report

    Report Number
    0001825034-2015-02015
    Event Type
    Injury
    Date Received
    May 12, 2015
    Date of Event
    April 12, 2015
    Report Date
    June 1, 2015
    Manufacturer
    EBI, LLC DBA BIOMET SPINE & BONE HEALING TECHNOLOG
    Product Code
    HSB
    PMA / PMN Number
    PK072161
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. DURING THE EVALUATION, IT WAS NOTED THE ROOT CAUSE OF THE EVENT WAS MOST LIKELY DUE TO CROSS-THREADING OF THE NAIL WHEN ATTACHED TO INSERTER CAUSED BY IMPROPER SURGICAL TECHNIQUE.

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER WARNINGS, NUMBER 4 STATES, "CORRECT HANDLING OF IMPLANTS IS EXTREMELY IMPORTANT." EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A FEMORAL FIXATION PROCEDURE ON (B)(6) 2015. DURING THE PROCEDURE, THE NAIL BECAME DISLODGED FROM THE GUIDE WHEN THE SURGEON ATTEMPTED TO REPOSITION IT WAS UNABLE TO RELOAD THE NAIL. A SHORTER NAIL WAS UTILIZED TO COMPLETE THE PROCEDURE. A 30 MINUTE DELAY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310275 FEMORAL NAIL RETRO 12MM X 380MM ROD, FIXATION HSB EBI, LLC DBA BIOMET SPINE & BONE HEALING TECHNOLOG N/A 239030

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Hospitalization| R