BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERNALOCK BLU SYSTEM BLADE, STERNALOCK POWERDRIVER

    MDR report key: 8233105 · Received January 10, 2019

    Report

    Report Number
    0001032347-2019-00024
    Event Type
    Malfunction
    Date Received
    January 10, 2019
    Report Date
    February 20, 2019
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    PMA / PMN Number
    K161896
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. THE PRODUCT IDENTITY COULD NOT BE CONFIRMED DUE TO THE PRODUCT NOT BEING RETURNED. THE STERNALOCK BLU SYSTEM BLADE, STERNALOCK POWERDRIVER (PART# 73-1191, LOT# UNK) COULD NOT BE VISUALLY EVALUATED OR FUNCTIONALLY TESTED DUE TO THE PRODUCT NOT BEING RETURNED AND NO PHOTOS BEING PROVIDED BY THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. 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. THE FOLLOWING SECTIONS WERE UPDATED: DATE RECEIVED BY MANUFACTURER. PMA/510(K) NUMBER CORRECTED FROM K110574 AND K161896 MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2019-00021-1, 0001032347-2019-00022-1, 0001032347-2019-00023-1, AND 0001032347-2019-00067.

    Description of Event or Problem · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED AND ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). UNIQUE IDENTIFIER (UDI) NUMBER: (B)(4). 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: 0001032347-2019-00022 THROUGH 0001032347-2019-00023.

    Description of Event or Problem · 1

    IT WAS REPORTED THE BLADE IS DULL. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26367 STERNALOCK BLU SYSTEM BLADE, STERNALOCK POWERDRIVER BLADE HRS BIOMET MICROFIXATION N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1