BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ PASS 70 DEGREE LEFT

    MDR report key: 7130403 · Received December 19, 2017

    Report

    Report Number
    0001825034-2017-11102
    Event Type
    Malfunction
    Date Received
    December 19, 2017
    Date of Event
    November 27, 2017
    Report Date
    March 22, 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
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CAT#904054 EZ PASS 70 DEGREE LEFT LOT#: NI. THE REPORTED EVENT COULD NOT BE CONFIRMED BASED ON LIMITED INFORMATION RECEIVED. NO PRODUCTS WERE RETURNED; THEREFORE, THE VISUAL AND DIMENSIONAL INSPECTIONS WERE NOT PERFORMED. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. 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, 356880. (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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: 0001825034-2017-11101. DISCARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ITEM WOULD NOT PASS THE WIRE THROUGH THE WHEELS ON THE DEVICE. THEREFORE, THE DEVICE DID NOT PERFORM AS EXPECTED. A REPLACEMENT WAS OPENED FROM THE SAME LOT; HOWEVER, THE SAME ISSUE OCCURRED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910686 EZ PASS 70 DEGREE LEFT PASSER HWQ ZIMMER BIOMET, INC. N/A 356880

    Patients

    Seq Age Sex Outcome Treatment
    1