BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JGRKNT 1.0MM MINI 3-0 NDLS

    MDR report key: 11259170 · Received February 1, 2021

    Report

    Report Number
    0001825034-2021-00094
    Event Type
    Malfunction
    Date Received
    February 1, 2021
    Date of Event
    January 4, 2021
    Report Date
    March 17, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBI
    UDI-DI
    00880304523418
    PMA / PMN Number
    K140908
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD 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.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICES: ITEM# 912082; LOT# 474830; JGRKNT 1.0MM MINI 3-0 NDLS; ITEM# 912082; LOT# 424010; JGRKNT 1.0MM MINI 3-0 NDLS. FOREIGN: EVENT OCCURRED IN (B)(6). 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: 0001825034-2021-00095, 0001825034-2021-00096. DISCARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON COULDN'T INSERT THE ANCHOR SINCE THE SLEEVE DIDN'T WORK PROPERLY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157390 JGRKNT 1.0MM MINI 3-0 NDLS SPORTSMED, IMPLANTS MBI ZIMMER BIOMET, INC. N/A 827960 00880304523418

    Patients

    Seq Age Sex Outcome Treatment
    1 SEE H10 NARRATIVE