BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JUGGERKNOT SOFT ANCHORS JUGGERKNOT MINI

    MDR report key: 7328878 · Received March 9, 2018

    Report

    Report Number
    0001825034-2018-01503
    Event Type
    Malfunction
    Date Received
    March 9, 2018
    Date of Event
    February 9, 2018
    Report Date
    June 18, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBI
    PMA / PMN Number
    PK110879
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    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 NOT CONFIRMED BOTH SUTURES AND BOTH INSERTERS WERE RETURNED BACK ARE VISUALLY CONFORMING TO THE PRINTS. VISUAL INSPECTION IDENTIFIED NO DAMAGES TO EITHER OF THE DEVICES AS SEEN IN THE PHOTOS ATTACHED. A DIMENSIONAL ANALYSIS WAS CONFORMING TO PRINT SPECIFICATIONS. FUNCTIONAL TESTING IS NOT POSSIBLE AS THE DEVICE WAS RETURNED DISASSEMBLED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: MFR#0001825034-2018-01822. ADDITIONAL CONCOMITANT MEDICAL PRODUCTS: JUGGERKNOT SOFT ANCHORS JUGGERKNOT MINI, PN: 912080 LN: 792240. (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO SUTURE ANCHORS WOULD NOT DISENGAGE. NO PATIENT IMPACT WAS REPORTED. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170747 JUGGERKNOT SOFT ANCHORS JUGGERKNOT MINI FASTENER, FIXATION MBI ZIMMER BIOMET, INC. N/A 792240

    Patients

    Seq Age Sex Outcome Treatment
    1