BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WIRE COLLET

    MDR report key: 1813009 · Received August 11, 2010

    Report

    Report Number
    1811755-2010-00907
    Event Type
    Malfunction
    Date Received
    August 11, 2010
    Date of Event
    July 13, 2010
    Report Date
    July 14, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HRX
    PMA / PMN Number
    K943323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER AND AN INVESTIGATION IS ANTICIPATED. THIS REPORT WILL BE UPDATED IF ADDITIONAL INFO FROM THE INVESTIGATION REQUIRES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A REPAIR OF A FRACTURED HUMERUS, A WIRE BECAME STUCK WITHIN THE COLLET. A SECOND DRILL SET WAS OPENED AND ANOTHER WIRE BECAME STUCK IN THE WIRE COLLET. THE WIRE WAS EVENTUALLY REMOVED USING A MALLET. THIS DELAYED THE CASE BY 30 MINUTES REQUIRING ADDITIONAL ANESTHESIA FOR THE PT. THERE WAS NO MEDICAL INTERVENTION REQUIRED AND NO ADVERSE CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WIRE COLLET SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTACHM HRX STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR