BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JUGGERKNOT 1.4MM SHRT W/NDLS

    MDR report key: 9837026 · Received March 16, 2020

    Report

    Report Number
    0001825034-2020-01084
    Event Type
    Malfunction
    Date Received
    March 16, 2020
    Date of Event
    March 9, 2020
    Report Date
    August 12, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBI
    PMA / PMN Number
    K110145
    Removal / Correction Number
    N/A
    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. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED THAT THE TIP OF THE DEVICE HAD ONE PRONG FRACTURED AND NOT RETURNED. EDS SEMI-QUANTITATIVE ELEMENTAL ANALYSIS CONFIRMED THAT THE JUGGERKNOT INSERTER TIP MATERIAL TO BE CONSISTENT WITH NITINOL ALLOY. FRACTURED JUGGERKNOT SOFT ANCHOR INSERTER TIPS WERE ANALYZED BY OPTICAL MICROSCOPY AND SCANNING ELECTRON MICROSCOPE (SEM) REVEALING SHEARED DUCTILE OVERLOAD DIMPLES INDICATING A BENDING OVERLOAD FAILURE. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D1, D4, D10, G4, G7, H1, H2, H3, H6, H10 D4 MULTIPLE LOTS WERE INVOLVED IN THE REPORTED EVENT LOT# 398880 UDI# (01)00880304520820(17)240130(10)398880 MANUFACTURING DATE- JAN 30, 2019 EXPIRATION DATE- JAN 30, 2024 LOT# 585050 UDI# (B)(4). MANUFACTURING DATE- SEP 26, 2018 EXPIRATION DATE- SEP 26, 2023 LOT# 683840 UDI# (B)(4). MANUFACTURING DATE- SEP 22, 2018 EXPIRATION DATE- SEP 22, 2023 ONE HANDLE WAS RETURNED AND EVALUATED. UPON VISUAL INSPECTION THERE WAS NO ITEM OR LOT NUMBER VISIBLE ON THE DEVICE. THE TIP OF THE DEVICE HAD ONE PRONG FRACTURED AND NOT RETURNED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

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

    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). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE INSERTER FRACTURED AFTER THE ANCHOR WAS IMPLANTED IN THE PATIENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301268 JUGGERKNOT 1.4MM SHRT W/NDLS SPORTSMED, INSTRUMENTS MBI ZIMMER BIOMET, INC. N/A SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1