BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON/MODIFIED TRINKLE REAMER

    MDR report key: 2456271 · Received February 7, 2012

    Report

    Report Number
    1811755-2012-00406
    Event Type
    Malfunction
    Date Received
    February 7, 2012
    Date of Event
    December 7, 2011
    Report Date
    January 20, 2012
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ATTACHMENT WAS RECEIVED AT THE MFR FOR SERVICE. DURING THE EVALUATION A RED SUBSTANCE RESIDUE WAS FOUND NEAR THE BALLS AND DRIVESHAFT OF THE DEVICE WHILE A VISUAL INSPECTION WAS PERFORMED UNDER MAGNIFICATION. BASED ON THE QUALITY INVESTIGATION DETAILS, THIS SUBSTANCES WAS LIKELY (B)(6), WHICH IS A LUBRICANT THAT IS USED IN THIS DEVICE. IT'S POSSIBLE THE LUBRICANT MIGRATED FROM THE REAR BEARING AFTER THE INITIAL CLEANING OF THE PRODUCT.

    Description of Event or Problem · 1

    THE ATTACHMENT WAS RETURNED TO THE MFR FOR SERVICE, AND DURING THE EVALUATION A RED SUBSTANCE WAS FOUND ON THE DEVICE. THERE WAS NO PT INVOLVEMENT AT THE MFR DURING THIS EVENT. THERE WERE NO ADVERSE CONSEQUENCES REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK