BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRYKER

    MDR report key: 782486 · Received November 15, 2006

    Report

    Report Number
    MW1041010
    Event Type
    Injury
    Date Received
    November 15, 2006
    Date of Event
    October 18, 2006
    Report Date
    November 15, 2006
    Manufacturer
    STRYKER ENDO
    Product Code
    NBH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING ARTHROSCOPIC ANKLE SURGERY, THE SMALL JOINT GRASPER (BASKET) BROKE OFF IN THE SURGICAL AREA. THE PORTION OF THE INSTRUMENT THAT BROKE OFF REQUIRED A SMALL OPEN INCISION IN ORDER TO BE RETRIEVED. IT IS DIFFICULT TO FULLY IDENTIFY THIS INSTRUMENT. THE NUMBER PRINTED UNDER THE STRYKER NAME IS ENTERED. THE INSTRUMENT CONTAINS ANOTHER IMBEDDED NUMBER OF 9KL. STRYKER ENDO HAS INDICATED THAT NEITHER OF THESE NUMBERS ACCURATELY DETAILS THE CORRECT PART NUMBER FOR THE INSTRUMENT. ATTEMPTING TO DETERMINE THE CORRECT STRYKER DIVISION AND PART NUMBER HAD DELAYED REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER SMALL JOINT GRASPER NBH STRYKER ENDO * *

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention