BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIBIAL ALIGNMENT ANKLE CLAMP EM

    MDR report key: 4123342 · Received September 26, 2014

    Report

    Report Number
    0002249697-2014-03652
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 3, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    PMA / PMN Number
    K123486
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE INVESTIGATION RESULTS WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING A FRACTURED TRIATHLON TIBIAL ALIGNMENT ANKLE CLAMP WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: ONE OF THE FLIPPERS OF THE TIBIAL ALIGNMENT ANKLE CLAMP WAS FRACTURED. THE DEVICE WAS MANUFACTURED TO REVISION G OF THE PRODUCT DRAWING. -MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED BECAUSE THERE IS NO INDICATION THE EVENT WAS RELATED TO PATIENT FACTORS -DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATES ALL DEVICES ACCEPTED INTO FINAL STOCK MET SPECIFICATIONS. -COMPLAINT HISTORY REVIEW: THERE HAVE BEEN OTHER SIMILAR REPORTED EVENTS FOR THIS LOT ID. CONCLUSIONS: THE INVESTIGATION CONCLUDED THAT THE ANKLE CLAMP FLIPPER BROKE FROM MULTIPLE OVERLOAD CONDITIONS DURING USE. NCR AND CAPA WERE OPENED TO PERFORM A ROOT CAUSE INVESTIGATION. CAPA WAS CLOSED. CORRECTIVE ACTION: NCR AND CAPA WERE RAISED TO EVALUATE THE DESIGN OF THE ANKLE CLAMP AND FURTHER INVESTIGATE THE ROOT CAUSE. THE CAPA WAS CLOSED. ROOT CAUSE DESCRIPTION: 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. ACTION DESCRIPTION: THE DESIGN REVIEW PROCEDURE HAS BEEN IMPLEMENTED TO PROVIDE REQUIREMENTS FOR RIGOROUS DESIGN REVIEW OF ALL NEW PRODUCTS. CREATE A DFMECA AND A RISK TABLE TO IDENTIFY AND MITIGATE THE ALL POTENTIAL FAILURES MODES. CHANGE THE CURRENT MATERIAL TO A MORE APPROPRIATE MATERIAL FOR THE DESIGNED USE.

    Description of Event or Problem · 1

    THE TIBIAL ALIGNMENT ANKLE CLAMP WAS NOTICED BROKEN WHEN INSPECTING THE TRAY BEFORE BEING SENT OUT.

    Description of Event or Problem · 1

    THE TIBIAL ALIGNMENT ANKLE CLAMP WAS NOTICED BROKEN WHEN INSPECTING THE TRAY BEFORE BEING SENT OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602580 TIBIAL ALIGNMENT ANKLE CLAMP EM INSTRUMENT MBH STRYKER ORTHOPAEDICS-MAHWAH N5H21

    Patients

    Seq Age Sex Outcome Treatment
    1 Other