BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRA DRIVE 7MM DISK DRILL

    MDR report key: 3691922 · Received March 21, 2014

    Report

    Report Number
    0001825034-2014-02028
    Event Type
    Injury
    Date Received
    March 21, 2014
    Date of Event
    February 18, 2014
    Report Date
    February 21, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JXE
    PMA / PMN Number
    PK031280
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 5 STATES, "THE PATIENT IS TO BE WARNED THAT ULTRA-DRIVE TOOL TIPS CAN BREAK OR OTHERWISE FAIL DURING SURGERY, AND THAT FRAGMENTS OF BROKEN TOOL TIPS CAN REMAIN AT THE SURGICAL SITE AFTER SURGERY."

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TOTAL HIP REVISION PROCEDURE ON (B)(6) 2014. DURING THE PROCEDURE, THE TIP OF THE DISK DRILL FRACTURED IN THE PATIENT'S DISTAL FEMUR CANAL. THE FRACTURED TIP REMAINS IN THE PATIENT. AN ULTRA DRIVE TIP WAS UTILIZED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169567 ULTRA DRIVE 7MM DISK DRILL DEVICE JXE BIOMET ORTHOPEDICS N/A 670180

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention