BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARTIVA

    MDR report key: 10574615 · Received September 23, 2020

    Report

    Report Number
    3009351194-2020-00013
    Event Type
    Injury
    Date Received
    September 23, 2020
    Date of Event
    August 26, 2020
    Report Date
    August 26, 2020
    Manufacturer
    CARTIVA, INC
    Product Code
    LXH
    PMA / PMN Number
    K181348
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H6: THE PRODUCT WAS RETURNED FOR REVIEW. VISUAL EXAMINATION OF THE RETURNED PART CONFIRMS / SHOWS - THE MTK-10 DRILL WAS RETURNED AND ASSESSED AT CARTIVA, INC. VISUAL INSPECTION FOUND NO OUTWARD SIGNS OF DAMAGE OR MISUSE. ACCORDING TO MANUFACTURING RECORDS, THE DRILL BIT WAS PRODUCED PER SPECIFICATION.

    Description of Event or Problem · 0

    ALLEGEDLY, THE SURGEON WAS USING THE REAMER AND WAS UNABLE TO REAM THE BONE DUE TO THE REAMER BEING DULL. THIS RESULTED IN SHARDS FALLING OFF THE REAMER AND BURNING OF THE BONE. ANOTHER SECOND DISPOSABLE KIT WAS USED TO COMPLETE THE SURGERY.

    Additional Manufacturer Narrative · 1

    NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    ALLEGEDLY, THE SURGEON WAS USING THE REAMER AND WAS UNABLE TO REAM THE BONE DUE TO THE REAMER BEING DULL. THIS RESULTED IN SHARDS FALLING OFF THE REAMER AND BURNING OF THE BONE. ANOTHER SECOND DISPOSABLE KIT WAS USED TO COMPLETE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1039412 CARTIVA ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH CARTIVA, INC MTK-10 181466

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention