BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUDSON/MODIFIED TRINKLE ATTACH

    MDR report key: 2833142 · Received November 7, 2012

    Report

    Report Number
    1811755-2012-04000
    Event Type
    Injury
    Date Received
    November 7, 2012
    Date of Event
    October 9, 2012
    Report Date
    October 9, 2012
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED DURING FAILURE ANALYSIS THAT DEBRIS AND A NON-STRYKER BIT WERE FOUND INSIDE THE DEVICE. THE STRYKER IFU WARNS ONLY STRYKER APPROVED ACCESSORIES SHOULD BE USED. INTERNAL DEBRIS CAN ALSO INTERFERE WITH THE FUNCTIONALITY OF THE DEVICE. THEREFORE, IT IS LIKELY THE REPORTED EVENT WAS DUE TO THE USE OF A NON-STRYKER BIT AND INTERNAL DEBRIS.

    Description of Event or Problem · 1

    THE HUDSON MODIFIED TRINKLE ATTACHMENT WAS SENT FOR EVALUATION DUE TO A COMPETITOR DRILL BIT BREAKING OFF IN THE DEVICE DURING A PROCEDURE. NO BROKEN PARTS FELL INTO THE SURGICAL SITE. THE EVENT LEAD TO A 30 MINUTE DELAY IN WHICH ADDITIONAL ANESTHESIA WAS ADMINISTERED TO THE PT. THE PT DID NOT REQUIRE ANY FURTHER MEDICAL INTERVENTION FOLLOWING THE ANESTHESIA. THERE WERE NO FURTHER ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON/MODIFIED TRINKLE ATTACH KIJ STRYKER INSTRUMENTS KALAMAZOO 07289

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK UNK DRILL BIT