BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLITAIRE SYSTEM INSTRUMENT

    MDR report key: 2820843 · Received November 6, 2012

    Report

    Report Number
    0002242816-2012-00076
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Date of Event
    October 2, 2012
    Report Date
    October 8, 2012
    Manufacturer
    EBI, LLC.
    Product Code
    MQP
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION CONFIRMED THE REPORTED EVENT. THE "PRONG" OF THE INSERTER WHICH AIDS IN SECURING THE IMPLANT TO THE INSTRUMENT WAS BROKEN OFF. THE MANUFACTURING RECORDS WERE REVIEWED FINDING TWO DMRR'S UNRELATED TO THE FUNCTIONALITY OF THE DEVICE; NO OTHER ANOMALIES WERE FOUND IN THE DOCUMENTATION. THE PROBABLE UNDERLYING ROOT CAUSE FOR THE DAMAGE IS INSTRUMENT FRACTURE DUE TO LOSS OF MECHANICAL INTEGRITY DURING USAGE OF THE DEVICE SINCE MANUFACTURING IN 2008.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PRONG OF THE INSERTER GUIDE BROKE OFF AND RESULTED IN A DELAY OF 30 MINUTES OR GREATER. THE PATIENT OUTCOME WAS REPORTED TO BE "OK".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLITAIRE SYSTEM INSTRUMENT 14MM SOLITAIRE INSERTER GUIDE MQP EBI, LLC. N/A 726440

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization