BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUAL TRIGGER ROTARY

    MDR report key: 2974321 · Received February 22, 2013

    Report

    Report Number
    0001811755-2013-00358
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 5, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS IS IN PROGRESS; ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETED. (B)(4): FAILURE ANALYSIS IS IN PROGRESS; ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS CONFIRMED. THE HANDPIECE DREW HIGH CURRENT AND STARTED TO HEAT UP DUE TO NON-STRYKER MODIFICATIONS TO THE E-BOX. BASED ON A REVIEW OF COMPLAINT TRENDING, NON-STRYKER MODIFICATIONS TO THE E-BOX CAN CAUSE HIGH CURRENT DRAW, HEAT, AND INTERMITTENT OR COMPLETE LOSS OF POWER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DUAL TRIGGER ROTARY WAS SMOKING DURING TESTING. WHEN THE BATTERY WAS REMOVED FROM THE HANDPIECE IT WAS NOTED THAT THE BATTERY WAS MELTED AS A RESULT. THE EVENT DID NOT OCCUR DURING A PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE DEVICES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DUAL TRIGGER ROTARY WAS SMOKING DURING TESTING. WHEN THE BATTERY WAS REMOVED FROM THE HANDPIECE IT WAS NOTED THAT THE BATTERY WAS MELTED AS A RESULT. THE EVENT DID NOT OCCUR DURING A PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78879 DUAL TRIGGER ROTARY INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT KIJ STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4) SYSTEM 6 BATTERY