BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPRESSION TARGETING DEVICE

    MDR report key: 2704912 · Received August 17, 2012

    Report

    Report Number
    0001825034-2012-01330
    Event Type
    Injury
    Date Received
    August 17, 2012
    Date of Event
    July 27, 2012
    Report Date
    July 30, 2012
    Manufacturer
    BIOMET
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    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. PRODUCT IDENTIFICATION TO REVIEW DEVICE HISTORY RECORDS WAS NOT PROVIDED. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-01330/01331).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. EXAMINATION OF RETURNED DEVICE FOUND EVIDENCE OF WEAR BUT APPEARS FUNCTIONAL. (NOTE: BIOMET, INC. ACQUIRED THE TRAUMA PRODUCT LINE FROM DEPUY ORTHOPAEDICS, INC. (DEPUY) ON (B)(4) 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 1825034-2012-01330-1/01331-1).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT AN ANKLE PROCEDURE UTILIZING THE COMPRESSION TARGETING DEVICE AND STATIC/DYNAIC SHEATH ON (B)(6) 2012. DURING THE PROCEDURE THE SHEATHS WOULD NOT FIT ONTO THE TARGETING DEVICE RESULTING IN THE SHEATH FALLING TO FLOOR. THE SURGEON FINISHED THE PROCEDURE WITHOUT THE REPORTED DEVICE RESULTING IN A DELAY OVER THIRTY MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPRESSION TARGETING DEVICE ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH BIOMET N/A BJ3AA4

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R