BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN GAMMA 3 NAIL

    MDR report key: 16397424 · Received February 17, 2023

    Report

    Report Number
    0009610622-2023-00039
    Event Type
    Injury
    Date Received
    February 17, 2023
    Date of Event
    December 3, 2014
    Report Date
    February 17, 2023
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 TRAUMA SURGERY, TRAUMA CENTER MURNAU, GERMANY¿. THE ARTICLE CAN BE FOUND AT HTTPS://LINK.SPRINGER.COM/ARTICLE/10.1007/S00402-014-2121-6. 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 PUBLISHED BY THE ¿DEPARTMENT OF TRAUMA SURGERY, TRAUMA CENTER MURNAU, GERMANY¿. THE TITLE OF THIS REPORT IS, ¿BREAKAGE OF CEPHALOMEDULLARY NAILING IN OPERATIVE TREATMENT OF TROCHANTERIC AND SUBTROCHANTERIC FEMORAL FRACTURES¿, PUBLISHED ON DECEMBER 3, 2014, WHICH IS ASSOCIATED WITH THE STRYKER ¿GAMMA 3 NAILING SYSTEM. THE ARTICLE CAN BE FOUND AT HTTPS://LINK.SPRINGER.COM/ARTICLE/10.1007/S00402-014-2121-6. THIS REPORT INCLUDES AN ANALYSIS OF THE CLINICAL DATA THAT WAS COLLECTED ON 453 PATIENTS, AND THE CASES IN THIS STUDY RANGE FROM FEBRUARY 2005 TO DECEMBER 2013. DURING THE REVIEW OF THE LITERATURE, IT WAS NOT POSSIBLE TO ESTABLISH A SPECIFIC DEVICE DETAIL, PATIENT INFORMATION, AND CURRENTLY NO ADDITIONAL DEVICE INFORMATION IS AVAILABLE; HOWEVER, IT WAS REPORTED THAT 1 PATIENT EXPERIENCED IMPLANT BREAKAGE, SECONDARY TO NONUNION, WHICH REQUIRED REVISION SURGERY OF A LONG GAMMA NAIL WITH ADDITIONAL APPLICATION OF RECOMBINANT HUMAN PROTEIN AND AUXILIARY LOCKING PLATE FIXATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119968 UNKNOWN GAMMA 3 NAIL ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Male Required Intervention