BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUGGERKNOT 1.4MM SHRT W/NDLS

    MDR report key: 19667285 · Received July 3, 2024

    Report

    Report Number
    0001825034-2024-01760
    Event Type
    Injury
    Date Received
    July 3, 2024
    Date of Event
    March 19, 2024
    Report Date
    November 14, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBI
    PMA / PMN Number
    K110145
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). G2: FOREIGN- JAPAN. D4: LOT# 0002409336 OR 0002409336. UDI#: (B)(4). EXPIRATION DATE: JAN 21, 2027, OR MAY 3, 2027. H4: JAN 21, 2022, OR MAY 3, 2022. IT IS UNKNOWN WHICH LOT OUT OF THE TWO FRACTURED. HENCE BOTH THE LOTS ARE REPORTED. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE HAS BEEN DISCARDED BY THE HOSPITAL AS A BIOHAZARD. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D2, G3, G6, H1, H2, H3, H6, H11. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. DEVICE IS USED FOR TREATMENT. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) 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

    IT WAS REPORTED THAT THE TIP OF THE INSERTER FRACTURED AND TWO PIECES OF THE FRACTURED PIECES RETAINED INSIDE THE PATIENT'S BURR HOLE. NO ADVERSE EVENT HAS BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759503 JUGGERKNOT 1.4MM SHRT W/NDLS FASTENER, FIXATION MBI ZIMMER BIOMET, INC. SEE H11 NARRATIVE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11 NARRATIVE.