BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON/MODIFIED TRINKLE REAMER

    MDR report key: 3092186 · Received May 3, 2013

    Report

    Report Number
    0001811755-2013-01017
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 20, 2013
    Report Date
    April 20, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON DISASSEMBLY FOR VISUAL INSPECTION, THE PRESENCE OF A SUBSTANCE WAS CONFIRMED.

    Description of Event or Problem · 1

    WHILE TESTING THE HUDSON/MODIFIED TRINKLE REAMER DURING ROUTINE SERVICING, IT WAS REPORTED THAT THERE WAS A SUBSTANCE ON THE SHAFT WHICH COULD INDICATE THAT THE DEVICE WAS LEAKING. THERE WAS NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES TO THE USER REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193766 HUDSON/MODIFIED TRINKLE REAMER INSTRUMENT, SURGICAL, ORTHOPED HWE STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1