BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN AFFIXUS ANTI-ROTATION SCREW

    MDR report key: 2794476 · Received October 17, 2012

    Report

    Report Number
    0001825034-2012-01959
    Event Type
    Injury
    Date Received
    October 17, 2012
    Report Date
    September 21, 2012
    Manufacturer
    BIOMET
    Product Code
    HRS
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. NOTE: BIOMET, INC. ACQUIRED THE TRAUMA PRODUCT LINE FROM DEPUY ORTHOPAEDICS, INC. ("DEPUY") ON (B)(6) 2012 ("CLOSING DATE"). PURSUANT TO THE WRITTEN AGREEMENT BETWEEN BIOMET AND DEPUY, BIOMET AGREED TO BE RESPONSIBLE FOR REGULATORY REPORTING FOR EVENTS WHICH OCCURRED AFTER THE CLOSING DATE REGARDLESS OF THE ENTITY THAT ACTUALLY MANUFACTURED THE PRODUCT. BECAUSE THE PRODUCT THAT IS THE SUBJECT MATTER WAS MANUFACTURED BEFORE THE CLOSING DATE, PLEASE BE ADVISED THAT THE SUBJECT PRODUCT WAS MANUFACTURED BY DEPUY AND NOT BIOMET.) THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 0001825034-2012-01959/01960).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT AFFIXUS PROXIMAL FEMORAL NAIL PROCEDURE IN (B)(6). SUBSEQUENTLY, PATIENT HAS TO UNDERGO A REVISION SURGERY ON AN UNKNOWN DATE DUE TO THE LAG SCREW SLIDING LATERALLY AND THE ANTI-ROTATION SCREW STAYING IN THE SAME LOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN AFFIXUS ANTI-ROTATION SCREW PLATE, FIXATION HRS BIOMET N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R