BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JUGGERKNOT 1.4MM 1 #1 MB 10PK

    MDR report key: 6832392 · Received August 30, 2017

    Report

    Report Number
    0001825034-2017-06854
    Event Type
    Malfunction
    Date Received
    August 30, 2017
    Date of Event
    July 28, 2017
    Report Date
    September 26, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBI
    PMA / PMN Number
    PK110145
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UDI: (B)(4). IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. 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)(6). THERAPY DATE - (B)(6) 2017. CONCOMITANT MEDICAL PRODUCT - JUGGERKNOT 1.4MM 1 #1 MB 10PK CATALOG # 912010 LOT # P03776. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPOTS WERE FILLED FOR THIS EVENT: 0001825034 - 2017 - 06853.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY TWO ANCHORS BROKE; ANOTHER PRODUCT WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612217 JUGGERKNOT 1.4MM 1 #1 MB 10PK FASTENER, FIXATION MBI BIOMET ORTHOPEDICS N/A P03776

    Patients

    Seq Age Sex Outcome Treatment
    1