BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUAL TRIGGER ROTARY

    MDR report key: 3926452 · Received July 10, 2014

    Report

    Report Number
    0001811755-2014-02462
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 13, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED DISASSEMBLY WAS CONFIRMED BY A MANUFACTURER REPAIR TECHNICIAN THROUGH VISUAL INSPECTION. SIGNS OF THIRD PARTY WORK ON THE INTERNAL COMPONENTS OF THE DEVICE WERE NOTED DURING FAILURE ANALYSIS. UNAUTHORIZED MODIFICATION OF THESE COMPONENTS IS A POTENTIAL CAUSE OF THE REPORTED DISASSEMBLY. THE DEVICE INSTRUCTIONS FOR USE STATES THAT NO SERVICE SHOULD BE ATTEMPTED ON THE DEVICE SYSTEM COMPONENTS AND THAT ALL CONCERNS SHOULD BE DIRECTED TO STRYKER SERVICE. STRYKER RECOMMENDS THAT ALL FAILURES AND MAINTENANCE ASSOCIATED WITH ITS DEVICES SHOULD BE DIRECTED TO TRAINED STRYKER SERVICE PROFESSIONALS.

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS IS IN PROGRESS; ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING CONDUCTED AT THE MANUFACTURER FACILITY, AN O-RING OF THE DEVICE DISASSEMBLED. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE MANUFACTURER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING CONDUCTED AT THE MANUFACTURER FACILITY AN O-RING OF THE DEVICE DISASSEMBLED. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE MANUFACTURER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405064 DUAL TRIGGER ROTARY INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1