BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEMORAL CANAL TIP

    MDR report key: 2891066 · Received November 14, 2012

    Report

    Report Number
    2648666-2012-00359
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 17, 2012
    Report Date
    October 18, 2012
    Manufacturer
    STRYKER INSTRUMENTS PUERTO RICO
    Product Code
    FQH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED TO THE MAUNFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FEMORAL CANAL TIP WAS FRACTURED DURING THE COURSE OF A PROCEDURE. NO FRACTURED PIECES FELL INTO THE SURGICAL SITE. THERE WERE NO ADVERSE CONSEQUENCES AND NO MEDICAL INTERVENTION. A BACK-UP DEVICE WAS USED AND THERE WAS NO SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FEMORAL CANAL TIP FQH STRYKER INSTRUMENTS PUERTO RICO UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK