BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGET DEVICE GAMMA3®

    MDR report key: 6122788 · Received November 22, 2016

    Report

    Report Number
    0009610622-2016-00520
    Event Type
    Malfunction
    Date Received
    November 22, 2016
    Date of Event
    October 31, 2016
    Report Date
    November 1, 2016
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    PMA / PMN Number
    K123401
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE MANUFACTURER BECAME AWARE BY AN (B)(4) PUBLICATION "HOW EVOLUTION OF THE NAILING SYSTEM IMPROVES RESULTS AND REDUCES ORTHOPEDIC COMPLICATIONS: MORE THAN 2000 CASES OF TROCHANTERIC FRACTURES TREATED WITH THE GAMMA NAIL SYSTEM¿, PUBLISHED ON 14TH DECEMBER 2015 REGARDING THE GAMMA SYSTEM (SGN, TGN, GAMMA3 ¿ ALL TROCHANTERIC NAILS) THAT IN SUM 63 PATIENTS HAD BEEN OBSERVED PRESENTING 11 ADVERSE EVENTS IN A PERIOD FROM (B)(6) 1997 TO (B)(6) 2011. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE OR PATIENT INFORMATION FROM THE ARTICLE, A REVIEW OF THE COMPLAINT HANDLING DATABASE REVEALED THAT THE EVENTS HAD NOT BEEN REPORTED BY THE HOSPITAL OR BY THE AUTHOR OF THE PUBLICATION, THEREFORE 11 COMPLAINTS WERE INITIATED RETROSPECTIVELY. THIS PRODUCT INQUIRY ADDRESSES 4 INTRA-OPERATIVE MULTIPLE DISTAL DRILLING IN CONJUNCTION TO THE GAMMA3 SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771062 TARGET DEVICE GAMMA3® ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other