BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARXMEN MENISCAL REPAIR DEVICE CURVED

    MDR report key: 3953302 · Received July 23, 2014

    Report

    Report Number
    0001825034-2014-06387
    Event Type
    Injury
    Date Received
    July 23, 2014
    Report Date
    June 26, 2014
    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 OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER WARNINGS, NUMBER 6 STATES, "CORRECT HANDLING OF SUTURE IS EXTREMELY IMPORTANT. AVOID CRUSHING OR CRIMPING DAMAGE DUE TO APPLICATION OF SURGICAL INSTRUMENTS SUCH AS FORCEPS OR NEEDLE HOLDERS."

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A MENISCUS REPAIR PROCEDURE ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE MAXFIRE SUTURE SNAPPED CAUSING THE SURGEON TO PARTIALLY REMOVE THE PATIENT'S MENISCUS IN ORDER TO COMPLETE THE PROCEDURE. A 30 MINUTE DELAY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432028 MARXMEN MENISCAL REPAIR DEVICE CURVED FASTENER, FIXATION MBI BIOMET ORTHOPEDICS N/A 291680

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R