BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PCH BSKT RTRY 90D 3.4MM R CIG

    MDR report key: 8025210 · Received October 31, 2018

    Report

    Report Number
    1219602-2018-01467
    Event Type
    Malfunction
    Date Received
    October 31, 2018
    Date of Event
    October 11, 2018
    Report Date
    November 30, 2018
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    NBH
    UDI-DI
    03596010022653
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED BECAUSE THE DEVICE IN QUESTION HAS NOT BEEN RETURNED FOR EVALUATION. THUS, THE COMPLAINT COULD NOT BE VERIFIED AND A ROOT CAUSE COULD NOT BE DETERMINED WITH CONFIDENCE. IT IS DIFFICULT TO PERFORM AN ACCURATE EVALUATION OF A FAILURE WITHOUT HAVING THE FAILED PRODUCT OR THE PERTINENT CLINICAL DETAILS TO CONSIDER. AS SUCH THE COMPLAINT IS BEING CLOSED WITHOUT CONCLUSION. HOWEVER, IF THE PRODUCT IS RETURNED IN THE FUTURE THE COMPLAINT CAN BE REOPENED AND EVALUATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TRIGGER CAME OFF THE HANDLE DURING SURGERY. ALL PARTS WERE RETRIEVED FROM THE PATIENT. NOR DELAY OR PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862941 PCH BSKT RTRY 90D 3.4MM R CIG ACCESSORIES,ARTHROSCOPIC NBH SMITH & NEPHEW, INC. 0784 03596010022653

    Patients

    Seq Age Sex Outcome Treatment
    1