BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JGRKNT 1.0MM MINI 3-0 NDLS

    MDR report key: 16528659 · Received March 13, 2023

    Report

    Report Number
    0001825034-2023-00497
    Event Type
    Malfunction
    Date Received
    March 13, 2023
    Date of Event
    February 13, 2023
    Report Date
    April 21, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    DZL
    UDI-DI
    00880304523418
    PMA / PMN Number
    K140908
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS WERE NOT PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. ASSOCIATED PRODUCTS AND REPORTS: 0001825034-2023-00498-1, ITEM#912082; LOT#0002443045.

    Additional Manufacturer Narrative · 0

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT WAS DISCARDED BY HOSPITAL. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. ASSOCIATED PRODUCTS AND REPORTS: 0001825034-2023-00498. ITEM#912082; LOT#0002443045.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED DURING SURGERY THE CLEAR SLEEVE ON THE DEVICE WOULD NOT SLIDE AS INTENDED, CAUSING A MINOR DELAY IN SURGERY WHILE THE SURGEON PREPARED ANOTHER DEVICE. NO PIECES WERE RETAINED BY THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448405 JGRKNT 1.0MM MINI 3-0 NDLS SCREW, FIXATION, INTRAOSSEOUS DZL ZIMMER BIOMET, INC. NI 0002466225 00880304523418

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown