BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAS FIX FLUTED 3.2 DIA X 150

    MDR report key: 10395981 · Received August 12, 2020

    Report

    Report Number
    0009617840-2020-00003
    Event Type
    Injury
    Date Received
    August 12, 2020
    Date of Event
    July 23, 2020
    Report Date
    December 16, 2020
    Manufacturer
    ZIMMER CAS
    Product Code
    OLO
    PMA / PMN Number
    K182964
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. D4: UDI: (B)(4). PHYSICAL EVALUATION COULD NOT BE PERFORMED AS THE FLUTED PIN WAS NOT RETURNED FOR EVALUATION. VISUAL ANALYSIS WAS PERFORMED ON PICTURES WHICH SHOWS A STUCK PIN IN FEMORAL BONE, CONFIRMING THE REPORTED EVENT. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. 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.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WILL NOT 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 · 1

    DURING SET UP FOR A ROBOTIC ASSISTED KNEE ARTHROPLASTY, IT WAS NOTED THAT THE TIP OF A 3.2MM FLUTED PIN FRACTURED IN THE FEMORAL CORTEX; THIS WAS LEFT IN PLACE TO PREVENT FURTHER DAMAGE. NO ADDITIONAL ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862733 CAS FIX FLUTED 3.2 DIA X 150 ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO ZIMMER CAS N/A H190494

    Patients

    Seq Age Sex Outcome Treatment
    1 Other