BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR MICROPLASTY CUP INSERTER 3/8" THREAD

    MDR report key: 1802165 · Received August 17, 2010

    Report

    Report Number
    1825034-2010-00332
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Date of Event
    July 16, 2010
    Report Date
    July 19, 2010
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF RECEIVING CERTIFICATE OF CONFORMANCE SHOWED THAT LOT HAD NO RECORDED ANOMALY OR DEVIATION. THE ASSOCIATED PACKAGE INSERT STATES THE FOLLOWING WARNING: "INTRAOPERATIVE FRACTURE OR BREAKING OF INSTRUMENTS HAS BEEN REPORTED. SURGICAL INSTRUMENTS ARE SUBJECT TO WEAR WITH NORMAL USAGE. INSTRUMENTS THAT HAVE EXPERIENCED EXTENSIVE USE OR EXCESSIVE FORCE ARE SUSCEPTIBLE TO FAILURE." EVALUATION OF RETURNED DEVICE FOUND THAT BOTH SIDES OF THE FRACTURE SURFACE SHOW CONCENTRIC PROGRESSION MARKS SURROUNDING A 0.4MM OVAL INSTANTANEOUS ZONE THAT IS CONSISTENT WITH A ROTATING FATIGUE FRACTURE FAILURE. (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA.(B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: THIS REPORT FILED (B)(6) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A PROCEDURE UTILIZING AN ACETABULAR CUP INSERTER ON (B)(6) 2010. DURING THE PROCEDURE, THE LOCK PIN FRACTURED OFF THE INSTRUMENT. THERE WAS NO DELAY TO THE PROCEDURE OR INJURY TO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A PROCEDURE UTILIZING AN ACETABULAR CUP INSERTER ON (B)(6) 2010. DURING THE PROCEDURE, THE LOCK PIN FRACTURED OFF THE INSTRUMENT. THERE WAS NO DELAY TO THE PROCEDURE OR INJURY TO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A PROCEDURE UTILIZING ACETABULAR CUP INSERTER ON (B)(6) 2010. DURING THE PROCEDURE, THE LOCK PIN FRACTURED OFF THE INSTRUMENT. THERE WAS NO DELAY TO THE PROCEDURE OR INJURY TO THE PATIENT AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODULAR MICROPLASTY CUP INSERTER 3/8" THREAD ORTHO, MANUAL SURGICAL INSTRUMENT LXH BIOMET ORTHOPEDICS N/A 0000R1

    Patients

    Seq Age Sex Outcome Treatment
    1