BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM MULTIDIRECT SCREW 85MM

    MDR report key: 7022417 · Received November 10, 2017

    Report

    Report Number
    0001825034-2017-10157
    Event Type
    Injury
    Date Received
    November 10, 2017
    Date of Event
    January 17, 2017
    Report Date
    November 10, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HRS
    PMA / PMN Number
    PK111663
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE EXPLANTED - IT IS UNKNOWN IF THE SCREW WAS REMOVED IN THE (B)(6) 2017 PROCEDURE. MEDICAL PRODUCT: PROXIMAL TIBIAL LOCKING PLATE, CATALOG#: 816235807, LOT#: NI. 4.0MM CANC LOCKING SCREW, CATALOG#: 816140085, LOT#: NI. CORTICAL SCREW, CATALOG#: 815037046, LOT#: NI. MULTIDIRECT SCREW, CATALOG#: 816335065, LOT#: NI (QTY: 2). 3.5MM CORT LOCKING SCREW, CATALOG#: 816135042, LOT#: NI. 3.5MM CORT LOCKING SCREW, CATALOG#: 816135040, LOT#: NI. 3.5MM CORT LOCKING SCREW, CATALOG#: 816135050, LOT#: NI. 3.5MM MULTIDIRECT SCREW, CATALOG#: 816335075, LOT#: NI (QTY: 2). 3.5MM MULTIDIRECT SCREW, CATALOG#: 816335085, LOT#: NI. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION(S) IS/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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2016-05039-1, 0001825034-2017-03672, 03673, 03674, 03677, 03678, 03679, 03680, 10152, 10156, AND 10157.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING REMOVAL OF A RIGHT PROXIMAL TIBIAL PLATE APPROXIMATELY TWENTY-TWO MONTHS POST-IMPLANTATION, IT WAS FOUND THAT SOME OF THE SCREWS WERE STRIPPED AND SOME OF THE LOCKING SCREWS WERE COLD WELDED TO THE PLATE. ULTIMATELY, THE PLATE AND ONE SCREW WERE LEFT IMPLANTED IN THE PATIENT, AS THEY WERE UNABLE TO COMPLETE THE REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800871 3.5MM MULTIDIRECT SCREW 85MM PLATE, FIXATION HRS ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention