BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ PASS 70 DEGREE RIGHT

    MDR report key: 6931729 · Received October 9, 2017

    Report

    Report Number
    0001825034-2017-08243
    Event Type
    Malfunction
    Date Received
    October 9, 2017
    Date of Event
    February 9, 2015
    Report Date
    October 9, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HWQ
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT DISCARDED AND WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN RISK DOCUMENTATION. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LABRIAL TEAR REPAIR PROCEDURE, THE SURGEON WENT TO PASS A SUTURE FROM THE JUGGERKNOT THROUGH THE LABRUM AND THE WIRE WOULD NOT ADVANCE. THE WIRE DID ADVANCE BEFORE THE DEVICE WAS PLACED INTO THE CANNULA BUT WOULD NOT ONCE PASSED THROUGH THE LABRUM. ATTEMPTED TO RELOADED THE WIRE AFTER REMOVING FROM THE CANNULA AND IT WOULD STILL NOT ADVANCE. COMPLETED THE PROCEDURE WITH NO DELAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710941 EZ PASS 70 DEGREE RIGHT PASSER HWQ ZIMMER BIOMET, INC. N/A 269980

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR