BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN GAMMA 3 NAIL CASE 3

    MDR report key: 12042139 · Received June 22, 2021

    Report

    Report Number
    0009610622-2021-00574
    Event Type
    Malfunction
    Date Received
    June 22, 2021
    Date of Event
    December 10, 2019
    Report Date
    June 22, 2021
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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 DEPARTMENT OF ORTHOPAEDIC SURGERY, GANGNAM SACRED HEART HOSPITAL, IN SOUTH KOREA. THE TITLE OF THIS REPORT IS ¿GAMMA 3 U-BLADE LAG SCREWS IN PATIENTS WITH TROCHANTERIC FEMUR FRACTURES: ARE ROTATION CONTROL LAG SCREWS BETTER THAN OTHERS?¿ PUBLISHED ON DECEMBER 16, 2019, WHICH IS ASSOCIATED WITH THE STRYKER ¿GAMMA3 NAILING¿ SYSTEM. THE ARTICLE CAN BE FOUND AT HTTPS://DOI.ORG/10.1186/S13018-019-1427-Z. THIS REPORT INCLUDES RESEARCH DONE ON 185 PATIENTS BETWEEN THE PERIOD JANUARY 2011 AND JUNE 2016. 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 (3) CASES OF EXCESSIVE MIGRATION OF LAG SCREW. THE REPORT STATES THE CHANGE IN THE NECK SHAFT ANGLE WAS 2.2° ± 5.46.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    943298 UNKNOWN GAMMA 3 NAIL CASE 3 IMPLANT HSB STRYKER TRAUMA KIEL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1