BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VANGUARD INSTRUMENTS PS BOX REAMER 62.5 - 67.5MM

    MDR report key: 2071154 · Received April 27, 2011

    Report

    Report Number
    1825034-2011-00307
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 31, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HTO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF RETURNED COMPONENT FOUND THE TIP TO BE MISSING. THERE ARE AREAS OF WEAR ON THE SHARP ANODIZED CUTTING EDGES. FRACTURE ARTIFACTS SUGGEST THE FRACTURE WAS DUE TO A DUCTILE FRACTURE DUE TO A BENDING OVERLOAD. THIS REPORT FILED (B)(4), 2011.

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. 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 ASSOCIATED PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: "INTRAOPERATIVE FRACTURE OR BREAKING OF INSTRUMENTS HAS BEEN REPORTED. SURGICAL INSTRUMENTS ARE SUBJECT TO WEAR WITH NORMAL USAGE. INSTRUMENTS, WHICH HAVE EXPERIENCED EXTENSIVE USE OR EXCESSIVE FORCE, ARE SUSCEPTIBLE TO FRACTURE." (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT KNEE ARTHROPLASTY PROCEDURE UTILIZING A BOX REAMER ON (B)(6) 2011. DURING THE PROCEDURE, THE TIP OF THE REAMER FRACTURED. THE FRACTURED PIECE WAS RETRIEVED AND THERE WAS NO INJURY TO THE PATIENT OR DELAY TO THE PROCEDURE AS A RESULT. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VANGUARD INSTRUMENTS PS BOX REAMER 62.5 - 67.5MM REAMER HTO BIOMET ORTHOPEDICS N/A 679420

    Patients

    Seq Age Sex Outcome Treatment
    1