BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRA DRIVE 9.5MM DISK DRILL

    MDR report key: 2968261 · Received February 19, 2013

    Report

    Report Number
    0001825034-2013-00294
    Event Type
    Injury
    Date Received
    February 19, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 24, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JXE
    PMA / PMN Number
    PK031280
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    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 IT STATES, "INSTRUMENTS, WHICH HAVE EXPERIENCED EXTENSIVE USE OR EXCESSIVE FORCE, ARE SUSCEPTIBLE TO FRACTURE." THIS REPORT IS NUMBER 2 OF 8 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-00293 / 00300).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A RIGHT HIP ARTHROPLASTY ON (B)(6) 2011. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2011 DUE TO INFECTION. THE SURGEON REMOVED THE STEM AND HEAD AND REPLACED WITH BIOMET STEM AND HEAD AND ANTIBIOTIC BONE CEMENT. FURTHER, PATIENT WAS REVISED ON (B)(6) 2013 DUE TO INFECTION AND REMOVED ALL ITEMS AND REPLACED WITH BIOMET PRODUCT. DURING THE PROCEDURE, THE DISK DRILL BIT FRACTURE. TO COMPLETE THE PROCEDURE, THE DRILL WAS STILL USED, AS WELL AS A CEMENT REMOVAL TOOL. AS A RESULT, THE FRACTURED PIECE REMAINS IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71077 ULTRA DRIVE 9.5MM DISK DRILL DEVICE, NERVE CONDUCTION VELOCITY MEASUREMENT JXE BIOMET ORTHOPEDICS N/A 718210

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Hospitalization| R