BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOANER CORE UNIVERSAL DRIVER

    MDR report key: 3750593 · Received April 15, 2014

    Report

    Report Number
    0001811755-2014-01318
    Event Type
    Malfunction
    Date Received
    April 15, 2014
    Date of Event
    March 21, 2014
    Report Date
    March 21, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FAILURE WAS CONFIRMED BY THE REPAIR TECHNICIAN THROUGH FUNCTIONAL EVALUATION, DISASSEMBLY, AND VISUAL INSPECTION. UPON DISASSEMBLY FOR VISUAL INSPECTION IT WAS FOUND THAT THE TRIGGER WAS WORN. WEAR MAY LIMIT THE DESIGN FUNCTION OF THE DEVICE CAUSING THE FAILURE. THE TRIGGER ASSEMBLY WAS REPLACED. THE DEVICE WAS RETURNED TO STRYKER STOCK AFTER PASSING FINAL INSPECTION.

    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

    THE CORE UNIVERSAL DRIVER WAS RETURNED TO STRYKER INSTRUMENTS FOR SERVICE. DURING FUNCTIONAL TESTING BY A SERVICE TECHNICIAN, IT WAS FOUND THAT THE REVERSE TRIGGER WOULD NOT HOLD IN SAFE MODE. 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

    THE CORE UNIVERSAL DRIVER WAS RETURNED TO STRYKER INSTRUMENTS FOR SERVICE. DURING FUNCTIONAL TESTING BY A SERVICE TECHNICIAN, IT WAS FOUND THAT THE REVERSE TRIGGER WOULD NOT HOLD IN SAFE MODE. 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
    230078 LOANER CORE UNIVERSAL DRIVER DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1