BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JUGGERKNOT 1.4MM 1 #1 MB 10PK

    MDR report key: 9608175 · Received January 20, 2020

    Report

    Report Number
    0001825034-2020-00253
    Event Type
    Malfunction
    Date Received
    January 20, 2020
    Date of Event
    December 31, 2019
    Report Date
    June 3, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBI
    PMA / PMN Number
    K150768
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO RELATED DEVIATIONS OR ANOMALIES DURING MANUFACTURING. 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 IS AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). UDI#: (B)(4). CONCOMITANT MEDICAL PRODUCTS: JUGGERKNOT 1.4MM 1 #1 MB, 10PK CAT# 912010, LOT# P10242. JUGGERKNOT 1.4MM 1 #1 MB,10PK CAT# 912010, LOT# P10242. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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: 0001825034-2020-00254, 0001825034-2020-00255.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE TRYING TO SECURE THE LABRUM TO THE GLENOID, THE ANCHOR FRACTURED WHILE TYING THE KNOTS. THIS HAPPENED WITH THREE DIFFERENT ANCHORS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71522 JUGGERKNOT 1.4MM 1 #1 MB 10PK ORTHOPEDIC MANUAL SURGICAL INSTRUMENT MBI ZIMMER BIOMET, INC. NI P10242

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR