BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIPASS DISP NITINOL SINGLE

    MDR report key: 2533212 · Received April 12, 2012

    Report

    Report Number
    0001825034-2012-00451
    Event Type
    Injury
    Date Received
    April 12, 2012
    Date of Event
    March 6, 2012
    Report Date
    March 15, 2012
    Manufacturer
    BIOMET SPORTS MEDICINE
    Product Code
    HXO
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-00450 / 00451).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2012. DURING THE PROCEDURE, THE NITINOL GUIDE FRACTURED AFTER PASSING THROUGH THE ROTATOR CUFF TISSUE. PART OF THE GUIDE HAD TO BE RETRIEVED FROM THE SHOULDER, AND THE OTHER PART REMAINED STUCK IN THE PUNCH. A DELAY OF NINETY MINUTES OCCURRED BEFORE THE SURGERY COULD BE COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPASS DISP NITINOL SINGLE PUSHER, SOCKET HXO BIOMET SPORTS MEDICINE N/A 859210

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R