BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ PASS 30 DEGREE LEFT

    MDR report key: 7489812 · Received May 7, 2018

    Report

    Report Number
    0001825034-2018-03186
    Event Type
    Malfunction
    Date Received
    May 7, 2018
    Date of Event
    January 4, 2017
    Report Date
    May 29, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HWQ
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. AS RETURNED THE NITINOL IS JAMMED IN 30 DEGREE SUBASSY AND FUNCTIONAL CHECK COULD NOT BE PERFORMED. NO PHYSICAL DAMAGE SEEN ON THE 70 DEGREE SUBASSY AND NITINOL. UPON ROTATING THE WHEEL THE NITINOL DID NOT PASS THROUGH THE 70 DEGREE BEND. AFTER INSERTING THE TAIL OF THE NITINOL THROUGH THE DISTAL END OF THE 70 DEGREE BEND DEVICE, THE DEVICE FUNCTIONED AS INTENDED. IT IS POSSIBLE THAT THE NITINOL KITE DID NOT BEND AT THE 70 DEGREE TURN INITIALLY. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 904054, EZ PASS 70 DEGREE LEFT, 840550. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-03187.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE WIRE WOULD NOT RELOAD ONTO EITHER DEVICE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334433 EZ PASS 30 DEGREE LEFT FASTENER, FIXATION HWQ ZIMMER BIOMET, INC. N/A 681060

    Patients

    Seq Age Sex Outcome Treatment
    1