BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIDENT 0 DEG INSERT TRIAL 36MM

    MDR report key: 1903621 · Received November 16, 2010

    Report

    Report Number
    2249697-2010-01546
    Event Type
    Malfunction
    Date Received
    November 16, 2010
    Date of Event
    October 21, 2010
    Report Date
    October 21, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONCLUDED THAT THE FRACTURE OF THE DOME HOLE OF THE TRIAL INSERT WAS CAUSED BY A TORSIONAL OVERLOAD. DUE TO THE PRESENCE OF THE COUNTERBORE IN THE INSERT TRIAL, IF THE USER IS TO OVER-TIGHTEN THE CONTAINMENT SCREW, THE DOME OF THE INSERT TRIAL CAN FRACTURE IN A MANNER CONSISTENT WITH THE FRACTURE EVALUATED IN THIS INVESTIGATION. THE ROOT CAUSE OF THIS EVENT IS LIKELY USER RELATED. A REVIEW OF THE DEVICE MANUFACTURING HISTORY RECORDS FOR CATALOG # 2200-36E, LOT # 36162601, INDICATED THAT DEVICES WERE ACCEPTED INTO FINAL STOCK ON (B)(6) 2005 WITH NO REPORTED DISCREPANCIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "LINER TRIAL BROKE WHILE REMOVING. TRIAL REMOVED FROM FIELD. NO IMPACT ON CASE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT 0 DEG INSERT TRIAL 36MM INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA 36162601

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention