BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD FEMORAL/TIB PLATE IMPACTOR

    MDR report key: 3962007 · Received July 28, 2014

    Report

    Report Number
    0001825034-2014-06479
    Event Type
    Injury
    Date Received
    July 28, 2014
    Date of Event
    June 6, 2014
    Report Date
    September 3, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HWA
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER CARE AND HANDLING OF INSTRUMENTS, NUMBER 1 STATES, "SURGICAL INSTRUMENTS AND INSTRUMENT CASES ARE SUSCEPTIBLE TO DAMAGE FOR A VARIETY OF REASONS INCLUDING PROLONGED USE, MISUSE, ROUGH OR IMPROPER HANDLING."

    Additional Manufacturer Narrative · 1

    EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. DURING THE EVALUATION, IT WAS NOTED THE COMPONENT LIKELY FRACTURED DUE TO EXTENSIVE USE AND IS CONSIDERED WORN BEYOND USEFUL LIFE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2014. DURING THE PROCEDURE, THE SCREW FROM THE IMPACTOR FRACTURED AND FELL INTO THE PATIENT. THE FRACTURED FRAGMENT WAS UNABLE TO BE RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437767 VANGUARD FEMORAL/TIB PLATE IMPACTOR IMPACTOR HWA BIOMET ORTHOPEDICS N/A ZB120203

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention