BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HFN 125 DEG 11MM X 180MM

    MDR report key: 3249857 · Received July 26, 2013

    Report

    Report Number
    0001825034-2013-02938
    Event Type
    Injury
    Date Received
    July 26, 2013
    Date of Event
    June 28, 2013
    Report Date
    June 28, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HSB
    PMA / PMN Number
    PK100238
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. (NOTE: BIOMET, INC. ACQUIRED THE TRAUMA PRODUCT LINE FROM DEPUY ORTHOPAEDICS, INC. (¿DEPUY¿) ON JUNE 16, 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 OR ACTUALLY SOLD THE PRODUCT TO THE HEALTHCARE PROVIDER. 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.) DEPUY ALSO SOLD THE PRODUCT THAT IS THE SUBJECT MATTER TO THE HEALTHCARE PROVIDER INVOLVED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT PROCEDURE UTILIZING AN AFFIXUS HIP FRACTURE NAIL ON (B)(6) 2013. WHEN THE SURGEON ATTEMPTED TO USE THE NAIL, IT WAS NOTICED THE SET SCREW WAS ALREADY ENGAGED AND WOULD NOT FIT THROUGH THE NAIL CAUSING A FORTY-FIVE MINUTE DELAY TO THE PROCEDURE. ANOTHER NAIL WAS USED TO FINISH THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350592 HFN 125 DEG 11MM X 180MM ROD, FIXATION HSB BIOMET ORTHOPEDICS N/A DNPBLO

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R