BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SMART TOE 16-MM ANGULATED

    MDR report key: 10380265 · Received August 7, 2020

    Report

    Report Number
    0008031020-2020-02106
    Event Type
    Injury
    Date Received
    August 7, 2020
    Date of Event
    June 17, 2013
    Report Date
    August 7, 2020
    Manufacturer
    STRYKER GMBH
    Product Code
    HTY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT COULD NOT BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER ADDITIONAL INFORMATION IS AVAILABLE. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED BECAUSE THE AFFECTED LOT NUMBER WAS NOT COMMUNICATED. IF ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE UPDATED. DEVICE DISPOSITION IS UNKNOWN.

    Description of Event or Problem · 1

    THE MANUFACTURER BECAME AWARE OF A LITERATURE PUBLISHED BY (B)(6) HOSPITAL AND MEDICAL CENTER, IN USA. THE TITLE OF THIS REPORT IS ¿SMART TOE® IMPLANT VERSUS BURIED KIRSCHNER WIRE FOR PROXIMAL INTERPHALANGEAL JOINT ARTHRODESIS: A COMPARATIVE STUDY¿ WHICH IS ASSOCIATED WITH THE STRYKER ¿SMART TOE¿ SYSTEM. THE ARTICLE CAN BE FOUND AT HTTPS://DOI.ORG/10.1053/J.JFAS.2013.02.007. WITHIN THAT PUBLICATION WHICH INCLUDED 58 PATIENTS, POST-OPERATIVE COMPLICATIONS WERE REPORTED, WHICH ALLEGEDLY OCCURRED FROM 1 JANUARY 2007 TO 31 DECEMBER 2010. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE DETAILS OR PATIENT INFORMATION FROM THE REPORT, OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED COMPLAINTS. THEREFORE, NEW COMPLAINTS WERE INITIATED IN THE SYSTEM FOR THE POST-OPERATIVE COMPLICATIONS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES (4) CASES OF NON-UNION. THE REPORT STATES: ¿OSSEOUS UNION WAS ACHIEVED IN 68.9% OF SMART TOE IMPLANTS AND 82.1% OF BURIED K-WIRES; 50% OF THE 19-MM ANGULATED AND 57.1% OF THE 16-MM ANGULATED IMPLANTS RESULTED IN FIBROUS UNION.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844093 UNKNOWN SMART TOE 16-MM ANGULATED IMPLANT HTY STRYKER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other