BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXFIRE MARXMEN STRAIGHT MENISCAL REPAIR DEVICE SIZE 2-0 POLYESTER SUTURE

    MDR report key: 2852211 · Received November 30, 2012

    Report

    Report Number
    0001825034-2012-02516
    Event Type
    Injury
    Date Received
    November 30, 2012
    Date of Event
    October 30, 2012
    Report Date
    November 9, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBI
    PMA / PMN Number
    PK111564
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER WARNINGS, NUMBER 4 STATES, "CARE IS TO BE TAKEN TO ASSURE ADEQUATE FIXATION OF THE MENISCAL TISSUE AT THE TIME OF SURGERY. FAILURE TO ACHIEVE ADEQUATE FIXATION THROUGH IMPROPER POSITIONING OR PLACEMENT OF THE DEVICE CAN CONTRIBUTE TO A SUBSEQUENT UNDESIRABLE RESULT."

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A KNEE ARTHROSCOPY PROCEDURE ON (B)(6) 2012. DURING THE PROCEDURE, THE SURGEON IMPLANTED THE FIRST ANCHOR AND AS THE SURGEON WENT TO IMPLANT THE SECOND ANCHOR IT STUCK IN THE CHANNEL. THE SURGEON HAD TO REMOVE THE ANCHOR FROM THE PATIENT AND COMPLETED THE PROCEDURE WITH ANOTHER MARXMAN STRAIGHT WITH NO DELAY OR PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXFIRE MARXMEN STRAIGHT MENISCAL REPAIR DEVICE SIZE 2-0 POLYESTER SUTURE FASTENER, FIXATION MBI BIOMET ORTHOPEDICS N/A 161990

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R