BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIPASS DISPOSABLE NITINOL PUSHER SINGLE

    MDR report key: 4997574 · Received August 12, 2015

    Report

    Report Number
    0001825034-2015-03581
    Event Type
    Injury
    Date Received
    August 12, 2015
    Date of Event
    July 13, 2015
    Report Date
    August 18, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HXO
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE.

    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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: "TOP JAW MUST REMAIN FULLY CLOSED TO ENSURE PROPER SUTURE PASSING. FAILURE TO ENSURE JAW REMAINS FULLY CLOSED MAY RESULT IN DEVICE MALFUNCTION." EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT AN ARTHROSCOPIC PROCEDURE ON (B)(6) 2015. DURING THE PROCEDURE, THE NITINOL PUSHER DID NOT PUSH THE SUTURE THROUGH THE BYPASS SUTURE PASSER. A 40 MINUTE DELAY OCCURRED IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530659 BIPASS DISPOSABLE NITINOL PUSHER SINGLE PASSER, SOCKET HXO BIOMET ORTHOPEDICS N/A 367170

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention