BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUGGERKNOT 1.4MM SHRT W/NDLS

    MDR report key: 8421719 · Received March 14, 2019

    Report

    Report Number
    0001825034-2019-01113
    Event Type
    Injury
    Date Received
    March 14, 2019
    Date of Event
    March 4, 2019
    Report Date
    July 1, 2019
    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. CONCOMITANT MEDICAL PRODUCTS : THREE JUGGERKNOT PRODUCT IDENTIFICATIONS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. IT IS UNKNOWN AFTER FOLLOW-UP ATTEMPTS WHICH DEVICE THE FRACTURED TIP BELONGED TO. THE INFORMATION FOR THE TWO ADDITIONAL JUGGERKNOTS ARE AS FOLLOWS: ITEM NAME : JUGGERKNOT 1.4MM SHRT W/NDLS, CATALOG NUMBER: 912068, LOT NUMBER: 740060, UDI#: (B)(4), EXPIRATION DATE: MAY 25, 2023, MANUFACTURE DATE: MAY 25, 2018. ITEM NAME: JUGGERKNOT 1.4MM SHRT W/NDLS, CATALOG NUMBER: 912068, LOT NUMBER: 963380, UDI#: (B)(4), EXPIRATION DATE: APR 6, 2023, MANUFACTURE DATE: APR 6, 2018. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED ONE OF THE PRONGS ON THE TIP OF THE INSERTER HAS FRACTURED HOWEVER, WAS NOT RETURNED WITH THE DEVICE. THE COMPLAINT IS CONFIRMED. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. 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). 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. IT WAS NOTED BY THE REPORTER THAT THERE ARE THREE POSSIBLE LOTS THAT CONTRIBUTED TO THIS EVENT, AND IT IS UNKNOWN WHICH LOT NUMBER ACTUALLY FRACTURED. THE THREE LOT NUMBERS FOR THE DEVICE 912068 ARE: 016700, 740060, OR 963380. (B)(4). REPORT SOURCE: EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, THE TIP OF THE DEVICE INSERTER FRACTURED WHEN THE SURGEON ATTEMPTED TO INSERT IT INTO THE PATIENT'S BURR HOLE. IT IS HIGHLY LIKELY THAT THE FRACTURED FRAGMENT WAS LEFT IN SITU. NO X-RAYS ARE AVAILABLE TO CONFIRM THIS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214280 JUGGERKNOT 1.4MM SHRT W/NDLS FASTENER, FIXATION MBI ZIMMER BIOMET, INC. N/A 016700

    Patients

    Seq Age Sex Outcome Treatment
    1 Other