BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIBIAL ALIGNMENT ANKLE CLAMP EM

    MDR report key: 4221722 · Received November 3, 2014

    Report

    Report Number
    0002249697-2014-04128
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 9, 2014
    Report Date
    October 9, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K051146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT LOCATED FOR RETURN. 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: A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED AS NO LOT INFORMATION WAS PROVIDED. -COMPLAINT HISTORY REVIEW: A COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED AS NO LOT INFORMATION WAS PROVIDED. CONCLUSIONS: THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED THE DEVICE WAS NOT RETURNED. A CAPA WAS RAISED TO DOCUMENT ROOT CAUSE AND CORRECTIONS. ROOT CAUSE WAS DETERMINED TO BE DESIGN RELATED, THE MATERIAL SELECTED WAS INADEQUATE FOR DESIGNED USE. A MATERIAL DESIGN UPDATE WAS COMPLETED AND THE CAPA WAS CLOSED ON 10-MAR-2014. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PRIMARY LEFT KNEE SURGERY, THE ANKLE CLAMP WAS BROKEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PRIMARY LEFT KNEE SURGERY, THE ANKLE CLAMP WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703234 TIBIAL ALIGNMENT ANKLE CLAMP EM INSTRUMENT JWH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other