BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN GAMMA3 NAIL

    MDR report key: 11426363 · Received March 7, 2021

    Report

    Report Number
    0009610622-2021-00333
    Event Type
    Injury
    Date Received
    March 7, 2021
    Date of Event
    November 19, 2013
    Report Date
    March 5, 2021
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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.

    Description of Event or Problem · 1

    THE MANUFACTURER BECAME AWARE OF A LITERATURE PUBLISHED BY MUSCULOSKELETAL RESEARCH CENTER AT THE NYU HOSPITAL IN USA. THE TITLE OF THIS REPORT IS ¿THE EFFECT OF TWO DIFFERENT TROCHANTERIC NAIL LAG-SCREW DESIGNS ON FIXATION STABILITY OF FOUR-PART INTERTROCHANTERIC FRACTURES: A CLINICAL AND BIOMECHANICAL STUDY¿ WHICH IS ASSOCIATED WITH THE STRYKER ¿GAMMA3 NAILING¿ SYSTEM. THE ARTICLE CAN BE FOUND AT HTTPS://DOI.ORG/10.1007/S00776-013-0493-Z. THIS REPORT INCLUDES RESEARCH DONE ON 20 PATIENTS WHICH IS PUBLISHED ON NOVEMBER 19, 2013. 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 NONUNION WHICH WAS CONVERTED TO A HEMIARTHROPLASTY 5 MONTHS AFTER THE INDEX SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324802 UNKNOWN GAMMA3 NAIL IMPLANT HSB STRYKER TRAUMA KIEL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention