BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DVR PEG SMOOTH 2.0MM X 26MM

    MDR report key: 6692302 · Received July 7, 2017

    Report

    Report Number
    0001825034-2017-04543
    Event Type
    Malfunction
    Date Received
    July 7, 2017
    Date of Event
    June 7, 2017
    Report Date
    September 21, 2017
    Manufacturer
    BIOMET TRAUMA
    Product Code
    LXT
    PMA / PMN Number
    PK050932
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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

    THIS SUPPLEMENTAL REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IT IS UNKNOWN WHICH TWO PEGS WERE IMPLANTED, AND WHICH PEG WAS REMOVED AND REPLACED. CONCOMITANT DEVICES: PEG SMOOTH 2.0MM X 18MM CATALOG #: P18000 LOT #: NI, PEG SMOOTH 2.0MM X 24MM CATALOG #: P24000 LOT #: NI. THIS REPORT IS NUMBER 3 OF 3 MDRS FILED FOR THE SAME PATIENT (REFERENCE 0001825034-2017-04541 / 04542).

    Description of Event or Problem · 1

    IT IS REPORTED THAT DURING A DISTAL VOLAR RADIUS TRAUMA FIXATION PROCEDURE, WHEN THE SURGEON ATTEMPTED TO PLACE A SMOOTH PEG INTO THE PLATE, THE PEG BEGAN TO THREAD, BUT WOULD NOT FULLY SEAT INTO THE PLATE. THE PEG WAS THEN REPORTED TO BE DIFFICULT TO ADVANCE OR REMOVE. THE SURGEON USED A MULTI-DIRECTIONAL THREADED PEG IN THIS PEG HOLE INSTEAD. SUBSEQUENTLY, THE SAME OCCURRENCE HAPPENED ON TWO MORE PEG HOLES IN THE PLATE. THE SURGEON USED A LOCKING TOWER TO HELP IMPLANT THESE PEGS AND GET THEM TO EVENTUALLY SEAT. THE PROCESS OF REMOVING AND REPLACING THE SMOOTH PEGS ADDED AN ADDITIONAL TEN (10) MINUTES TO THE PROCEDURE. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474959 DVR PEG SMOOTH 2.0MM X 26MM APPLIANCE, FIXATION LXT BIOMET TRAUMA N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR