BEUDAMED
    FDA Adverse Event Injury Summary report: N

    45 DEGREE LT ARTHROPASSER PII

    MDR report key: 5791761 · Received July 13, 2016

    Report

    Report Number
    0001825034-2016-02574
    Event Type
    Injury
    Date Received
    July 13, 2016
    Date of Event
    June 17, 2016
    Report Date
    June 17, 2016
    Manufacturer
    BIOMET SPORTS MEDICINE
    Product Code
    NBH
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS USER FACILITY IS OUTSIDE OF THE UNITED STATES. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. DEVICE REQUESTED, NOT YET RECEIVED.

    Description of Event or Problem · 1

    DURING AN ARTHROSCOPIC PROCEDURE, THE ARTHROPASSER FRACTURED AND PIECES HAD TO BE REMOVED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444880 45 DEGREE LT ARTHROPASSER PII ACCESSORIES, ARTHROSCOPIC NBH BIOMET SPORTS MEDICINE N/A 4561694

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention