BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN T2 ALPHA TIBIA K-WIRE

    MDR report key: 21026310 · Received December 27, 2024

    Report

    Report Number
    0009610622-2024-00976
    Event Type
    Injury
    Date Received
    December 27, 2024
    Date of Event
    November 29, 2024
    Report Date
    December 27, 2024
    Manufacturer
    STRYKER GMBH
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT HAS BEEN GENERATED BASED ON FINDINGS IDENTIFIED DURING POST MARKET SURVEILLANCE LITERATURE REVIEW PUBLISHED BY THE DEPARTMENT OF MECHANICAL ENGINEERING, UNIVERSITY OF MASSACHUSETTS LOWELL, LOWELL, MASSACHUSETTS, USA. THE ARTICLE CAN BE FOUND AT HTTPS://DOI.ORG/10.1002/JOR.25163. THE REPORTED EVENT COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER ADDITIONAL INFORMATION WAS RECEIVED FROM THE AUTHOR. MORE DETAILED INFORMATION ABOUT THE PATIENT'S MEDICAL HISTORY, THE EVENT DETAILS AND THE INVOLVED DEVICE(S) MUST BE AVAILABLE TO DETERMINE THE ROOT CAUSE. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THE INVESTIGATION WILL BE REOPENED AND RE-EVALUATED ACCORDINGLY.

    Description of Event or Problem · 0

    THE MANUFACTURER BECAME AWARE OF A LITERATURE ENTITLED ¿COMPARISON OF KWIRE INSERTION USING OSCILLATORY AND UNIDIRECTIONAL DRILLING MODES UNDER CONSTANT THRUST FORCE¿, PUBLISHED IN 2022, WHICH IS ASSOCIATED WITH THE IMN INSTRUMENTS (INTRAMEDULLARY NAILING SYSTEM). DURING THE REVIEW OF THE LITERATURE, IT WAS NOT POSSIBLE TO ESTABLISH A SPECIFIC DEVICE DETAIL, PATIENT INFORMATION, AND AT THIS TIME NO ADDITIONAL DEVICE INFORMATION IS AVAILABLE. FOR 1 PATIENT, THEY EXPERIENCED NECROSIS DUE TO HEAT GENERATION DURING THE KIRSCHNER WIRE (KWIRE) INSERTION PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2512429 UNKNOWN T2 ALPHA TIBIA K-WIRE ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other