BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAS FIX PIN 3.2D X 150MM STR

    MDR report key: 19986547 · Received August 14, 2024

    Report

    Report Number
    0009617840-2024-00014
    Event Type
    Malfunction
    Date Received
    August 14, 2024
    Report Date
    November 18, 2024
    Manufacturer
    ZIMMER CAS
    Product Code
    OLO
    PMA / PMN Number
    K210121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. THE DEVICE WAS NOT RETURNED. NO PICTURE(S) OR VIDEO WERE PROVIDED. DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). B3 DATE OF EVENT: UNKNOWN DATE IN JUNE 2024. IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY, THE SURGEON WAS INSERTING A DRILL PIN AT THE SURGICAL SITE WHEN IT BROKE INTO 2 PIECES. ONE OF THE PIECES WAS STILL IN THE PATIENT AND IT WAS DISCOVERED IMMEDIATELY. THE SURGEON WAS ABLE TO SAFELY REMOVE THE IMBEDDED PIECE. A SECOND PIN WAS USED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2373019 CAS FIX PIN 3.2D X 150MM STR ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO ZIMMER CAS N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female