BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROCEDURAL PACKS

    MDR report key: 1890156 · Received November 3, 2010

    Report

    Report Number
    1219602-2010-00268
    Event Type
    Malfunction
    Date Received
    November 3, 2010
    Date of Event
    September 29, 2010
    Report Date
    October 22, 2010
    Manufacturer
    SMITH & NEPHEW ENDOSCOPY MANSFIELD MANUFACTURE
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED FOR EVALUATION. (B)(4).

    Description of Event or Problem · 1

    TIP OF THE 15" PASSING PIN BROKE OFF IN THE FEMUR. SURGEON DECIDED NOT TO TRY TO RETRIEVE IT AND CONTINUED, USING A PIN FROM ANOTHER PAC. IMAGES FROM THE C-ARM / X-RAY SHOWED THE TIP OF THE PIN TO BE MORE POSTERIOR IN THE FEMUR THAN USUAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROCEDURAL PACKS ENDOBUTTON PAC LTX FREE HRX SMITH & NEPHEW ENDOSCOPY MANSFIELD MANUFACTURE 014893 50310810

    Patients

    Seq Age Sex Outcome Treatment
    1