BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIBIAL ALIGNMENT ANKLE CLAMP EM

    MDR report key: 3781227 · Received April 30, 2014

    Report

    Report Number
    0002249697-2014-01655
    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
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6). AN EVENT REGARDING A FRACTURED TRIATHLON TIBIAL ALIGNMENT ANKLE CLAMP WAS REPORTED. THE EVENT WAS CONFIRMED. VISUAL ANALYSIS CONFIRMED THE REPORTED EVENT. ONE OF THE DEVICE FLIPPERS FRACTURED. THE DEVICE WAS MANUFACTURED TO THE G REVISION. PATIENT FACTORS DID NOT CONTRIBUTE TO THE REPORTED EVENT. 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 NO OTHER SIMILAR REPORTED EVENTS FOR THIS LOT ID. 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 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIBIAL TOWER WITH THE ANKLE CLAMP ATTACHED WAS PULLED OFF PATIENT AND AS THE PLASTIC ARMS OF THE CLAMP SNAPPED BACK ONE OF THE ARMS SNAPPED OFF.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIBIAL TOWER WITH THE ANKLE CLAMP ATTACHED WAS PULLED OFF PATIENT AND AS THE PLASTIC ARMS OF THE CLAMP SNAPPED BACK ONE OF THE ARMS SNAPPED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259094 TIBIAL ALIGNMENT ANKLE CLAMP EM INSTRUMENT JWH STRYKER ORTHOPAEDICS-MAHWAH N5H21

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other