BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPASS DISPOSABLE PUSHER SINGLE PACK

    MDR report key: 6044955 · Received October 20, 2016

    Report

    Report Number
    0001825034-2016-04203
    Event Type
    Malfunction
    Date Received
    October 20, 2016
    Date of Event
    September 20, 2016
    Report Date
    September 21, 2016
    Manufacturer
    BIOMET SPORTS MEDICINE
    Product Code
    HXO
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 THE LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. 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

    DURING A ROTATOR CUFF REPAIR THE SUTURE WIRE KINKED AND BENT WHILE TRYING TO USE AND WOULD NOT PASS SUTURE AS INTENDED. A SECOND WIRE WAS USED WITH MINIMAL DELAY AND NO SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695095 BIPASS DISPOSABLE PUSHER SINGLE PACK ORTHOPEDIC MANUAL SURGICAL INSTRUMENT HXO BIOMET SPORTS MEDICINE N/A 869410

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR