BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUGGERKNOT 1.4MM 1 #1 MB 10PK

    MDR report key: 7244681 · Received February 6, 2018

    Report

    Report Number
    0001825034-2018-00549
    Event Type
    Injury
    Date Received
    February 6, 2018
    Date of Event
    March 1, 2017
    Report Date
    March 1, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBI
    PMA / PMN Number
    PK110145
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. TWO JUGGERKNOT'S WERE RETURNED FOR EVALUATION, AND VISUAL EXAMINATION DETERMINED THAT THE TIP OF EACH INSTRUMENT HAS FRACTURED. JUGGERKNOT NEEDLE TIP FRACTURES WERE ANALYZED BY SEM AND IT WAS FOUND THAT THEY WERE FRACTURED DUE TO OVERLOAD. DUCTILE OVERLOAD DIMPLES WERE IDENTIFIED ON BOTH THE NEEDLE TIP FRACTURES. EDS SEMI-QUANTITATIVE ELEMENTAL ANALYSIS OF BOTH THE NEEDLE TIPS REVEAL THAT THEY WERE CONSISTENT WITH NITINOL, SHOWING NI, TI, C, O, N, AND NA AS MAJOR ELEMENTS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION(S) IS/ARE REQUIRED. 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) CONCOMITANT MEDICAL PRODUCTS: 912010, JUGGERKNOT 1.4 MM 1 #1 MB 10PK, P04204. (B)(6). PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND 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 REPORTS: 0001825034-2017-02721.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BANKART REPAIR PROCEDURE, THE INSERTER TIPS FOR TWO ANCHORS FRACTURED WHILE IMPLANTING THE SUTURE ANCHOR. THE SURGERY WAS COMPLETED WITH ANOTHER ANCHOR, AFTER RETRIEVING THE FRACTURED PIECES FROM THE PATIENT'S WOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE JUGGERKNOT FRACTURED DURING A BANKART PROCEDURE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87525 JUGGERKNOT 1.4MM 1 #1 MB 10PK FASTENER, FIXATION MBI ZIMMER BIOMET, INC. N/A P04204

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention