BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGRD PS BOX REAMER 62.5-67.5

    MDR report key: 3100602 · Received May 8, 2013

    Report

    Report Number
    0001825034-2013-01328
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    March 19, 2013
    Report Date
    April 12, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HTO
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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, 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. CARE MUST BE TAKEN TO AVOID COMPROMISING THEIR EXACTING PERFORMANCE." THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-01328/ 01329).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY ON (B)(6) 2013. DURING THE PROCEDURE WHILE THE SURGEON WAS REAMING, THE INSTRUMENT FRACTURED. THE PIECES OF THE INSTRUMENT FELL INTO THE PATIENT'S WOUND. THIS HAPPENED WITH TWO SEPARATE REAMERS. THE PIECES WERE RECOVERED FROM THE PATIENT AND THE SURGEON COMPLETED THE PROCEDURE WITH NEW REAMERS FROM THE KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201931 VANGRD PS BOX REAMER 62.5-67.5 REAMER HTO BIOMET ORTHOPEDICS N/A 283070

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R