BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUGGERKNOT 1.4MM SHRT W/NDLS

    MDR report key: 9823795 · Received March 12, 2020

    Report

    Report Number
    0001825034-2020-01070
    Event Type
    Injury
    Date Received
    March 12, 2020
    Date of Event
    January 27, 2020
    Report Date
    August 6, 2020
    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

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G4, G7, H1, H2, H3, H6, H10 IT IS UNKNOWN WHICH LOT IS INVOLVED: LOT: 381030 MFG DATE: JUN 11, 2019 STERILE DATE: JUN 11, 2024 UDI: (B)(4). LOT: 931210 MFG DATE: JUL 17, 2019 STERILE DATE: JUL 17, 2024 UDI: (B)(4). LOT: 928690 MFG DATE: JUL 16, 2019 STERILE DATE: JUL 16, 2024 UDI: (B)(4). VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED THAT THE TIP OF THE DEVICE HAS FRACTURED AND WAS NOT RETURNED. 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). REPORT SOURCE: (B)(6). IT IS UNKNOWN WHICH LOT IS INVOLVED: LOT: 381030. LOT: 931210. LOT: 928690. 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 REPORT WILL BE SUBMITTED. PRODUCT NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSTRUMENT FRACTURED AND THE TIP WAS RETAINED IN THE PATIENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288873 JUGGERKNOT 1.4MM SHRT W/NDLS FASTNER, FIXATION MBI ZIMMER BIOMET, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other