BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TROCHANTERIC NAIL KIT, TI GAMMA3 Ø11X180MM X 125°

    MDR report key: 3116427 · Received May 16, 2013

    Report

    Report Number
    0009610622-2013-00260
    Event Type
    Malfunction
    Date Received
    May 16, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 19, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-KIEL
    Product Code
    HSB
    PMA / PMN Number
    K034002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION CONCLUSION: THE REPORTED ISSUE COULD NOT BE CONFIRMED AS THE PACKAGING WAS RETURNED ONLY FRAGMENTARY. THE CUSTOMER DEFINED THE SET SCREW TO BE THE PRIMARY PRODUCT. THE SET SCREW IS PART OF THE TROCHANTERIC NAIL KIT. NO CONCOMITANT PRODUCTS WERE REPORTED. NO DEVIATIONS WERE FOUND DURING REVIEW OF THE MANUFACTURING DOCUMENTS (DHR). THE REVIEW OF THE DHR REVEALED THAT THE SET SCREW WAS INSERTED IN THE PACKAGE LIKE SPECIFIED (LYING IN A FOAM CAGE). BECAUSE THE PRODUCT AND ITS PACKAGE WERE NOT COMPLETELY AVAILABLE FOR INVESTIGATION THE ROOT CAUSE COULD NOT BE DETERMINED. MOST LIKELY THE PACKAGING WAS OPENED IMPROVIDENTLY. THE CORRECT OPENING OF THE PACKAGING FOR THE NAIL KIT IS ILLUSTRATED UNDER ¿SAMPLE NAIL KIT PACKAGING FOR COMPARISON¿ WITHIN THE ATTACHED PHOTO DOCUMENTATION. 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 STUCK IN PACKAGING AND WHEN OPENED FLEW ONTO THE FLOOR. ANOTHER SET SCREW WAS OPENED AND CASE PROCEEDED IN NORMAL FASHION. NO HARM TO PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SET SCREW WAS STUCK IN PACKAGING AND WHEN OPENED FLEW ONTO THE FLOOR. ANOTHER SET SCREW WAS OPENED AND CASE PROCEEDED IN NORMAL FASHION. NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217907 TROCHANTERIC NAIL KIT, TI GAMMA3 Ø11X180MM X 125° IMPLANT HSB STRYKER OSTEOSYNTHESIS-KIEL K175717

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other