BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø10X340MM X 120°

    MDR report key: 3860887 · Received June 10, 2014

    Report

    Report Number
    0009610622-2014-00270
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 27, 2014
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    PMA / PMN Number
    K034002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVIATIONS WERE FOUND DURING REVIEW OF THE MANUFACTURING AND INSPECTION DOCUMENTS (DHR). THE NAIL KIT WAS DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. AN INVESTIGATION WAS NOT POSSIBLE DUE TO MISSING PRODUCT AND INFORMATION. DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. DEVICE RETAINED BY PATIENT.

    Description of Event or Problem · 1

    ON (B)(6) 2014, GAMMA3 LONG NAIL SURGERY WAS PERFORMED. THE FRACTURE WAS FOUND TO BE NON UNION AND THE NAIL WAS BROKEN. ON (B)(6) 2014, REVISION SURGERY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342993 LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø10X340MM X 120° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL K022EBA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention