BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PS TIBIAL INSERT TRIAL #4 - 9MM

    MDR report key: 1893772 · Received November 2, 2010

    Report

    Report Number
    2249697-2010-01450
    Event Type
    Malfunction
    Date Received
    November 2, 2010
    Date of Event
    October 12, 2010
    Report Date
    October 13, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    HWT
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: VISUAL INSPECTION INDICATED THAT THE DEVICE WAS RETURNED IN USED CONDITION WITH VISUAL DISCREPANCIES ATTRIBUTED TO FREQUENT USAGE. DAMAGE TO THE UNDERSIDE LOCKING PROFILE WAS OBSERVED, WITH A PIECE OF RADEL FRACTURED OFF COMPLETELY FROM THE POSTERIOR SIDE OF THE TRIAL. THE DAMAGE WAS LIKELY FROM IMPINGEMENT BETWEEN THE INSERT TRIAL AND TIBIAL TEMPLATE/HEADED PINS DURING PRIMARY TRIALING. THE INVESTIGATION CONCLUDED THAT THIS EVENT IS RELATED TO SIMILAR EVENTS WHERE TRIATHLON TIBIAL INSERT TRIALS FRACTURE, FRAGMENT OR CRACK WHEN SEATING ON THE TIBIAL TEMPLATES DUE TO INTERFERENCE WITH THE HEADED PINS FIXATING THE TEMPLATE TO THE TIBIA. THIS IS A DESIGN NON-CONFORMANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "THE TRIAL INSERT BROKE WHEN SURGEON TRIED PUTTING IT IN THE PT TO DO A TRIAL REDUCTION. HE SNAP IT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PS TIBIAL INSERT TRIAL #4 - 9MM INSTRUMENT HWT STRYKER ORTHOPAEDICS MAHWAH NA SMCYH16

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other