BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPDPASS LARIAT W/NIT 45DEG UP

    MDR report key: 6940810 · Received October 11, 2017

    Report

    Report Number
    0001825034-2017-08469
    Event Type
    Malfunction
    Date Received
    October 11, 2017
    Date of Event
    March 5, 2015
    Report Date
    October 11, 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
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS CONFIRMED IN THAT THE BOTTOM BIOMET SEAL HAD BEEN PEELED OPEN. PRESENCE OF ADHESIVE TRANSFER AS WELL AS THE REQUIREMENTS OF INSPECTION CRITERIA LEAD TO THE ASSUMPTION THAT THE PEELING OF THE SEAL OCCURRED AFTER THE PRODUCT LEFT BIOMET'S CONTROL, ALTHOUGH IT CANNOT BE DETERMINED. THE COOB SUMMARY IN THE COMPLAINT AND REVIEW OF OTHER PARTS FROM THE SAME LOT INDICATE THAT THE 2 PARTS WITH THE PEELED OPEN SEAL ARE PART OF AN ISOLATED INCIDENT. REVIEW OF THE COMPLAINT HISTORY IDENTIFIED AN ISSUE THAT WAS INVESTIGATED, AND IT WAS DETERMINED THAT NO FURTHER ACTION IS REQUIRED DUE TO THE TWO COMPLAINTS WERE ISOLATED INCIDENTS. REVIEW OF DEVICE HISTORY RECORDS FOUND THESE UNITS WERE RELEASED TO DISTRIBUTION WITH NO DEVIATIONS OR ANOMALIES. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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. THIS REPORT IS BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STERILE PACKAGING INSIDE OF BOX WAS NOT SEALED PROPERLY. THE OUTER PACKAGING, INCLUDING DUST COVER, WAS INTACT PRIOR TO OPENING. THERE WAS NO DELAY OR PATIENT INJURY. THIS WAS NOT A REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721297 SPDPASS LARIAT W/NIT 45DEG UP PASSER HWQ ZIMMER BIOMET, INC. N/A 961030

    Patients

    Seq Age Sex Outcome Treatment
    1