BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE TRIGGER ROTARY

    MDR report key: 3173060 · Received June 17, 2013

    Report

    Report Number
    0001811755-2013-01397
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 29, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT, UNINTENDED ACTIVATION, WAS DUPLICATED BY A MANUFACTURER REPAIR TECHNICIAN THROUGH FUNCTIONAL EVALUATION AND VISUAL INSPECTION. IT WAS CONFIRMED THAT THE DEVICE WOULD RUN BEFORE THE SAFETY WOULD CATCH DUE TO A CRACKED TRIGGER HOUSING FOUND. THE DEVICE WAS REPAIRED, ROUTINE MAINTENANCE WAS PERFORMED, AND IT WAS RETURNED TO THE USER FACILITY.

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS IN PROGRESS.

    Description of Event or Problem · 1

    THE DEVICE WAS SENT TO STRYKER INSTRUMENTS FOR REPAIR. DURING FUNCTIONAL TESTING BY A SERVICE TECHNICIAN AT THE MANUFACTURER FACILITY, IT WAS FOUND THAT THE DEVICE WAS RUNNING WITHOUT USER ACTIVATION WHILE IT WAS IN SAFE MODE. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED 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 DEVICE WAS SENT TO STRYKER INSTRUMENTS FOR REPAIR. DURING FUNCTIONAL TESTING BY A SERVICE TECHNICIAN AT THE MANUFACTURER FACILITY, IT WAS FOUND THAT THE DEVICE WAS RUNNING WITHOUT USER ACTIVATION WHILE IT WAS IN SAFE MODE. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED 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
    273706 SINGLE TRIGGER ROTARY INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT KIJ STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1