BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUGGERKNOT 1.4MM SHRT W/NDLS

    MDR report key: 10936103 · Received December 2, 2020

    Report

    Report Number
    0001825034-2020-04249
    Event Type
    Injury
    Date Received
    December 2, 2020
    Date of Event
    November 9, 2020
    Report Date
    April 8, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBI
    PMA / PMN Number
    K110145
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORTED EVENT WAS CONFIRMED AS VISUAL INSPECTION OF THE DEVICE IDENTIFIED THE TIP HAD FRACTURED. THE SUTURES AND ANCHORS WERE NOT RETURNED FOR EVALUATION. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. 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). EXACT LOT NUMBER IS UNKNOWN. POSSIBLE LOT #'S FOR THIS DEVICE INCLUDE: 124510 OR 116720 OR 899470 OR 962380. FOREIGN REPORT SOURCE: (B)(6). 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. 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 · 1

    IT WAS REPORTED APPROXIMATELY THREE (3) WEEKS AGO, THE TIP OF THE INSERTER WAS FRACTURED WHILE THE SURGEON WAS INSERTING THE ANCHOR INTO THE PATIENT'S BURR HOLE. SURGEON TRIED TO REMOVE THE FRACTURED PIECE FROM THE PATIENT, BUT WAS UNABLE TO. SURGEON DECIDED TO FINISH THE SURGERY WITHOUT REMOVING THE FRACTURED PIECE FROM THE PATIENT AND COMPLETED THE SURGERY WITH A SECOND DEVICE. THERE IS NO PLAN TO REVISE THE PATIENT TO REMOVE THE PIECE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1400343 JUGGERKNOT 1.4MM SHRT W/NDLS PROSTHESIS, SPORTS MED MBI ZIMMER BIOMET, INC. NI UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other