BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HFN 125 DEG 13MM X 180MM

    MDR report key: 2792215 · Received October 16, 2012

    Report

    Report Number
    0001825034-2012-01954
    Event Type
    Injury
    Date Received
    October 16, 2012
    Date of Event
    September 16, 2012
    Report Date
    September 17, 2012
    Manufacturer
    BIOMET
    Product Code
    HSB
    PMA / PMN Number
    PK100238
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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 FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION 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.)

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY THE ADDITIONAL INFORMATION AND EVALUATION, WHICH WERE UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.EXAMINATION OF RETURNED DEVICE FOUND THE EXACT CAUSE OF THE FRACTURE WAS INCONCLUSIVE. POST FRACTURE DAMAGE HAS OBFUSCATED MANY FRACTURE ARTIFACTS THAT WOULD SUGGEST FRACTURE DETAILS.REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER ADVERSE EVENTS: "CRACKING OR FRACTURE OF THE COMPONENTS OR LOSS OF FIXATION IN BONE ATTRIBUTABLE TO NONUNION, OSTEOPOROSIS, MARKEDLY UNSTABLE COMMINUTEDFRACTURES."

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT INITIAL AFFIXUS NAILING PROCEDURE ON (B)(6) 2012. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2012 DUE TO THE AFFIXUS NAIL FRACTURING. A SECOND AFFIXUS NAIL WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HFN 125 DEG 13MM X 180MM ROD, FIXATION HSB BIOMET N/A DMJBJB

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R