BEUDAMED
    FDA Adverse Event Other Summary report: N

    KARL STORZ

    MDR report key: 981404 · Received July 27, 2007

    Report

    Report Number
    2020550-2007-00021
    Event Type
    Other
    Date Received
    July 27, 2007
    Date of Event
    June 28, 2007
    Report Date
    July 26, 2007
    Manufacturer
    D & R PRODUCTS CO
    Product Code
    HTT
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Description of Event or Problem · 1

    DOCTOR WAS PERFORMING A SHOULDER DECOMPRESSION AND REPAIR OF A TORN ROTATOR CUFF WHEN HE NOTICED METAL PARTICLES APPEARING IN THE SITE AT THE BEGINNING OF PROCEDURE AND ADHERING TO SHOULDER BONE. DOCTOR NOTICED PARTICLES THROUGHOUT THE PROCEDURE BUT CONTINUED USING THE BURR. AFTER CONCLUDING PROCEDURE, HE USED A FULL RADIUS RESECTOR ALONG WITH SUCTION TO REMOVE METAL PARTICLES. DOCTOR WAS SUCCESSFUL IN GETTING THE PARTICLES OFF THE ARTICULAR SURFACE OF THE SHOULDER BONE, BUT SOME REMAINED ON THE TISSUE. THE SURFACE OF THE BONE WAS THE DR'S GREATEST CONCERN; HE WAS ABLE TO REMOVE APPROXIMATELY 90% OF THE FLAKES FROM THE PT SITE. NO FURTHER ACTION IS PLANNED BY DR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ BURR HTT D & R PRODUCTS CO 28205HDS 21565

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other