BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JGRKNT 1.0MM MINI 3-0 NDLS

    MDR report key: 11139133 · Received January 8, 2021

    Report

    Report Number
    0001825034-2020-04457
    Event Type
    Malfunction
    Date Received
    January 8, 2021
    Date of Event
    December 8, 2020
    Report Date
    February 26, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBI
    UDI-DI
    00880304523418
    PMA / PMN Number
    K110879
    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. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL EXAMINATION OF THE RETURNED PRODUCTS IDENTIFIED NO DAMAGES TO THE MAIN PORTION OF THE PRODUCTS (HANDLES). INSPECTION CONFIRMS THE RETURNED SUTURES HAVE BEEN TORN/BROKEN. DEVICE HISTORY RECORD (DHR) 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.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICES: 912082 JGRKNT 1.0MM MINI 3-0 NDLS 440000; 912082 JGRKNT 1.0MM MINI 3-0 NDLS 537470. FOREIGN- (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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2020 - 04456, 0001825034 - 2020 - 04458.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE SURGERY, THE SUTURES OF THE JUGGERKNOT BROKE WHEN THE SURGEON PULLED THE SUTURES AFTER HE INSERTED THE ANCHORS INTO THE BURR HOLE. THERE WAS A SURGICAL DELAY OF 15 TO 30 MINUTES FOR PREPARING AN ALTERNATE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35870 JGRKNT 1.0MM MINI 3-0 NDLS FASTENER, FIXATION MBI ZIMMER BIOMET, INC. N/A 554590 00880304523418

    Patients

    Seq Age Sex Outcome Treatment
    1 SEE NARRATIVE IN H10