BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ PASS 70 DEGREE LEFT

    MDR report key: 6181041 · Received December 16, 2016

    Report

    Report Number
    0001825034-2016-05229
    Event Type
    Malfunction
    Date Received
    December 16, 2016
    Date of Event
    November 16, 2016
    Report Date
    April 21, 2017
    Manufacturer
    BIOMET SPORTS MEDICINE
    Product Code
    HWQ
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. THE PRODUCT WAS VISUALLY EXAMINED. THERE DOES NOT APPEAR TO BE ANY DAMAGE TO THE DEVICE OR THE NITINOL KITE. THE PRODUCT WAS FUNCTIONALLY TESTED AND THE DEVICE WAS ABLE TO ADVANCE THE KITE WITH LITTLE ISSUE. NO NOTABLE ADDITIONAL FORCE HAD TO BE APPLIED TO THE WHEELS IN ORDER TO ADVANCE THE KITE. NO ISSUES COULD BE IDENTIFIED WITH THE RETURNED DEVICE. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE IDENTIFIED. A REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. A ROOT CAUSE WAS UNABLE TO BE DETERMINED AS NO PROBLEM COULD BE IDENTIFIED WITH THE DEVICE. 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

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Description of Event or Problem · 1

    DURING A PROCEDURE, THE PASSER WOULD NOT ADVANCE THE NITINOL WIRE. AFTER MULTIPLE ATTEMPTS TO ADVANCE THE WIRE, ANOTHER DEVICE WAS OPENED AND USED TO COMPLETE THE CASE WITH NO ADDITIONAL ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832936 EZ PASS 70 DEGREE LEFT PASSER HWQ BIOMET SPORTS MEDICINE N/A 840550

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR