BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIBIAL ALIGNMENT ANKLE CLAMP EM

    MDR report key: 3781228 · Received April 30, 2014

    Report

    Report Number
    0002249697-2014-01656
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 11, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K123486
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING A FRACTURED TRIATHLON TIBIAL ALIGNMENT ANKLE CLAMP WAS REPORTED. THE EVENT WAS NOT CONFIRMED. THERE IS NO INDICATION THE EVENT WAS RELATED TO PATIENT FACTORS. DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN OTHER SIMILAR REPORTED EVENTS FOR THIS LOT ID. CONCLUSIONS: THE EXACT ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE PRODUCT WAS NOT RETURNED FOR INSPECTION. NCR AND CAPA WERE OPENED TO PERFORM A ROOT CAUSE INVESTIGATION FOR SIMILAR EVENT DESCRIPTIONS. THE ROOT CAUSE OF CAPA DETERMINED: DESIGN REVIEW PROCEDURE(S), IN PLACE AT THE TIME OF DEVICE DEVELOPMENT WERE NOT COMPREHENSIVE ENOUGH TO IDENTIFY ALL POTENTIAL FAILURE MODES. NOT ALL POTENTIAL FAILURE MODES, INCLUDING THOSE INITIATED BY FORSEEABLE MISUSES OF THE DEVICE, WERE IDENTIFIED AND MITIGATED AT THE TIME OF DEVICE DEVELOPMENT. THE MATERIAL SELECTED WAS INADEQUATE FOR DESIGNED USE.

    Description of Event or Problem · 1

    WHEN THE DOCTOR WAS REMOVING THE ANKLE CLAMP FROM THE PATIENT'S ANKLE THE GREEN HINGE BROKE OFF.

    Description of Event or Problem · 1

    WHEN THE DOCTOR WAS REMOVING THE ANKLE CLAMP FROM THE PATIENT'S ANKLE THE GREEN HINGE BROKE OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258823 TIBIAL ALIGNMENT ANKLE CLAMP EM INSTRUMENT JWH STRYKER ORTHOPAEDICS-MAHWAH N5C11

    Patients

    Seq Age Sex Outcome Treatment
    1 Other