BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0 ALLTHREAD TI 2#2 MB

    MDR report key: 17304650 · Received July 12, 2023

    Report

    Report Number
    0001825034-2023-01579
    Event Type
    Injury
    Date Received
    July 12, 2023
    Date of Event
    June 21, 2023
    Report Date
    November 21, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBI
    UDI-DI
    00880304444263
    PMA / PMN Number
    K192942
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: ITEM# 902591; LOT# 0002477602. ITEM# CM-9011; LOT# 65637043. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT REMAINS IN THE PATIENT. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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 · 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 RECORDS 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PROCEDURE, THE SURGEON PLACED THE ANCHOR AND TIED THE KNOTS, BUT CAME BACK AND THE SUTURE WAS TORN. THE BLUE/WHITE STRAND WAS TIED DOWN AND THE ANCHOR REMAINS, WHILE THE WHITE STRAND WAS CUT OUT. ANOTHER DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE SURGERY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793946 5.0 ALLTHREAD TI 2#2 MB FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI ZIMMER BIOMET, INC. NI 0002462621 00880304444263

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Male Other SEE NARRATIVE IN H10.