BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VANGUARD PS BOX REAMER 70-75

    MDR report key: 3013389 · Received March 20, 2013

    Report

    Report Number
    0001825034-2013-00673
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Report Date
    February 15, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HTO
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    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 RECEIVING CERTIFICATE OF CONFORMANCE SHOWED 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."

    Additional Manufacturer Narrative · 1

    DIMENSIONAL EVALUATION FOUND COMPONENT TO BE WITHIN APPROPRIATE DESIGN SPECIFICATION. EVALUATION OF DEVICE FOUND EVIDENCE THAT FRACTURE MAY OCCUR AT THE TIP WHEN EXCESSIVE FORCE IS APPLIED OR THE INSTRUMENT IS INTRODUCED AT AN ANGLE. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER PRECAUTIONS IT STATES, "SURGICAL INSTRUMENTS ARE SUBJECT TO WEAR WITH NORMAL USAGE. INSTRUMENTS, WHICH HAVE EXPERIENCED EXTENSIVE USE OR EXCESSIVE FORCE, ARE SUSCEPTIBLE TO FRACTURE. SURGICAL INSTRUMENTS SHOULD ONLY BE USED FOR THEIR INTENDED PURPOSE. BIOMET RECOMMENDS THAT ALL INSTRUMENTS BE REGULARLY INSPECTED FOR WEAR AND DISFIGUREMENT."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY PROCEDURE UTILIZING A REAMER ON AN UNKNOWN DATE. DURING THE PROCEDURE, A PIECE OF THE REAMER FRACTURED AND A LARGER REAMER HAD TO BE USED TO COMPLETE THE PROCEDURE. THE FRACTURED PIECE DID NOT FALL INTO THE PATIENT'S WOUND AND NO PATIENT INJURY OCCURRED AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115993 VANGUARD PS BOX REAMER 70-75 REAMER HTO BIOMET ORTHOPEDICS N/A ZB101201

    Patients

    Seq Age Sex Outcome Treatment
    1