BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHORT GUIDE PIN

    MDR report key: 2868249 · Received December 7, 2012

    Report

    Report Number
    3004154314-2012-00004
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Date of Event
    November 12, 2012
    Report Date
    December 5, 2012
    Manufacturer
    ARTHROSURFACE, INC.
    Product Code
    KRR
    PMA / PMN Number
    K071413
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IN AN ARTHROSURFACE PATELLO-FEMORAL XL IMPLANT SURGERY, A GUIDE PIN BROKE AND THE PIN TIP WAS NOT RETRIEVED. THE PATIENT WAS NOTIFIED BY THE SURGEON WHEN IT WAS DISCOVERED POST-OPERATIVELY. THE SURGEON NOTED THAT IF HE HAD NOTICED THE PIN WAS LEFT IN THE PATIENT DURING THE CASE, THAT HE WOULD NOT HAVE ATTEMPTED TO RETRIEVE IT. THE PIN IS MADE OF 316 LVM SST PER ASTM F138 WHICH IS AN IMPLANTABLE GRADE MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHORT GUIDE PIN NONE KRR ARTHROSURFACE, INC. 2007-1510 75CB0922

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other