BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIBIAL ALIGNMENT ANKLE CLAMP EM

    MDR report key: 4241442 · Received November 10, 2014

    Report

    Report Number
    0002249697-2014-04219
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 16, 2014
    Report Date
    October 16, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K051146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 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. THE INVESTIGATION CONCLUDED THAT THE ANKLE CLAMP BROKE AT THE YOKE FROM MULTIPLE OVERLOAD CONDITIONS DURING USE. 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    TRIATHLON TIBIAL ANKLE CLAMP BROKE UPON REMOVAL AFTER TIBIAL RESECTION WAS MADE.

    Description of Event or Problem · 1

    TRIATHLON TIBIAL ANKLE CLAMP BROKE UPON REMOVAL AFTER TIBIAL RESECTION WAS MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722240 TIBIAL ALIGNMENT ANKLE CLAMP EM INSTRUMENT JWH STRYKER ORTHOPAEDICS-MAHWAH N5M01

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other