BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STATIC/DYNAMIC SHEATH

    MDR report key: 2704893 · Received August 17, 2012

    Report

    Report Number
    0001825034-2012-01331
    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 2 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 AND DEVICE EVALUATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. DIMENSIONAL EVALUATION FOUND SHAFT TO BE OVERSIZED AND OUT OF ROUND AT THE TIP. IT IS CLEAR THAT THE PART HAD BEEN USED BEFORE BASED ON THE WEAR MARKS ALONG THE ENTIRE SHAFT. THIS WOULD INDICATE THAT THE OUT OF ROUND CONDITION AND APPARENT DIAMETER FLARE OCCURRED DUE TO WEAR AND AFTER USE. (THIS REPORT IS NUMBER 2 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 STATIC/DYNAMIC SHEATH ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH BIOMET N/A E76K54

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R