BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIPASS PLASTIC NITINOL DISPOSABLE X1

    MDR report key: 2966410 · Received February 18, 2013

    Report

    Report Number
    0001825034-2013-00285
    Event Type
    Injury
    Date Received
    February 18, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 24, 2013
    Manufacturer
    BIOMET SPORTS MEDICINE
    Product Code
    HXO
    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

    EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA.

    Additional Manufacturer Narrative · 1

    EVALUATION OF RETURNED DEVICE FOUND EVIDENCE THAT INSTRUMENT FRACTURED DUE TO EXCESSIVE FORCE. 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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER WARNINGS, NUMBER 4 STATES, "DO NOT APPLY EXCESSIVE FORCE TO THE PUSHER ACTUATOR. REPEAT STEP 3A IF NECESSARY TO AVOID EXCESSIVE FORCE."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A ROTATOR CUFF PROCEDURE ON (B)(6) 2013. DURING THE PROCEDURE, THE TIP OF THE BIPASS DISPOSABLE PUSHER FRACTURED. THE FRACTURED PIECE HAD TO BE RETRIEVED FROM THE PATIENT. A NEW BIPASS DISPOSABLE PUSHER WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70574 BIPASS PLASTIC NITINOL DISPOSABLE X1 PUSHER, SOCKET HXO BIOMET SPORTS MEDICINE N/A 883930

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R