BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIBIAL ALIGNMENT ANKLE CLAMP EM

    MDR report key: 4093886 · Received September 16, 2014

    Report

    Report Number
    0002249697-2014-03514
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 27, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K051146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS PER SALES REP, ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. NOT RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING A FRACTURED TRIATHLON TIBIAL ALIGNMENT ANKLE CLAMP WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS THE PRODUCT WAS NOT RETURNED FOR INSPECTION. -MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS THERE IS NO INDICATION THE EVENT WAS RELATED TO PATIENT FACTORS -DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT 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 EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED THE DEVICE WAS NOT RETURNED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON INSPECTION OF INSTRUMENT, IT WAS NOTICED THAT THE ANKLE CLAMP WAS BROKEN. NO MORE INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON INSPECTION OF INSTRUMENT, IT WAS NOTICED THAT THE ANKLE CLAMP WAS BROKEN. NO MORE INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571624 TIBIAL ALIGNMENT ANKLE CLAMP EM INSTRUMENT JWH STRYKER ORTHOPAEDICS-MAHWAH PCZY

    Patients

    Seq Age Sex Outcome Treatment
    1 Other