BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUGGERKNOT 1.0MM MINI 2-0 NEEDLES

    MDR report key: 6932576 · Received October 9, 2017

    Report

    Report Number
    0001825034-2017-08277
    Event Type
    Injury
    Date Received
    October 9, 2017
    Date of Event
    September 12, 2017
    Report Date
    October 16, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBI
    PMA / PMN Number
    PK110879
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PART NUMBER: 912076, LOT NUMBER:202750 FOREIGN: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, BECAUSE IT WAS DISCARDED BY HOSPITAL AS BIOHAZARD. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001825034-2017-08278.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTIONS ARE REQUIRED. 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 · 1

    IT WAS REPORTED THAT DURING SURGERY, THE SURGEON INSERTED THE SUTURE ANCHOR, HOWEVER, THE ANCHOR CAME OUT OF THE PATIENT¿S BURR HOLE. THE SURGEON ATTEMPTED TO USE AN ALTERNATE ONE TO COMPLETE THE SURGERY, BUT, THE SAME INCIDENT OCCURRED AGAIN. THE SURGEON SUCCESSFULLY COMPLETED THE SURGERY WITH ANOTHER DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY, THE SURGEON INSERTED THE SUTURE ANCHOR, HOWEVER, THE ANCHOR CAME OUT OF THE PATIENT¿S BURR HOLE. THE SURGEON ATTEMPTED TO USE AN ALTERNATE ONE TO COMPLETE THE SURGERY, BUT, THE SAME INCIDENT OCCURRED AGAIN. THE SURGEON DRILLED ADDITIONAL BURR HOLES DUE TO FAILURE OF INITIAL DEVICE. THE SURGEON SUCCESSFULLY COMPLETED THE SURGERY WITH ANOTHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710711 JUGGERKNOT 1.0MM MINI 2-0 NEEDLES FASTENER, FIXATION MBI ZIMMER BIOMET, INC. N/A 202750

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention