BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TROCHANTERIC NAIL KIT, TI GAMMA3 Ø11X200MM X 125°

    MDR report key: 3181204 · Received June 21, 2013

    Report

    Report Number
    0009610622-2013-00357
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 6, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-KIEL
    Product Code
    HSB
    PMA / PMN Number
    K034002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSING ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED ISSUE WAS NOT CONFIRMED. THE SET SCREW IS PART OF THE TROCHANTERIC NAIL KIT. NO DEVIATIONS WERE FOUND DURING REVIEW OF THE MANUFACTURING AND INSPECTION DOCUMENTS (DHR). THE REVIEW OF THE DHR REVEALED THAT THE SET SCREW WAS INSERTED IN THE PACKAGE LIKE SPECIFIED (LYING IN A FOAM BOX). BECAUSE THE PRODUCT AND ITS PACKAGE WERE NOT AVAILABLE FOR INVESTIGATION THE ROOT CAUSE COULD NOT BE DETERMINED. MOST LIKELY THE SET SCREW STUCK IN THE FOAM/TIVEK LID DUE TO A TRANSPORT ISSUE OR THE PACKAGE WAS OPENED IMPROVIDENTLY. A MORE PRECISE EVALUATION IS NOT POSSIBLE DUE TO MISSING INFORMATION. NO DISCREPANCIES WERE DETECTED DURING RISK ANALYSIS REVIEW. NO NON-CONFORMITY IDENTIFIED; NO ACTIONS ARE IN PLACE.

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SET SCREW WAS MISSING IN THE PACKAGING. A REPLACEMENT WAS AVAILABLE (THEY USED THE SET SCREW FROM THE REPLACEMENT; SAME NAIL) .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SET SCREW WAS MISSING IN THE PACKAGING. A REPLACEMENT WAS AVAILABLE (THEY USED THE SET SCREW FROM THE REPLACEMENT; SAME NAIL) .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283849 TROCHANTERIC NAIL KIT, TI GAMMA3 Ø11X200MM X 125° IMPLANT HSB STRYKER OSTEOSYNTHESIS-KIEL K133498

    Patients

    Seq Age Sex Outcome Treatment
    1 Other