BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUAL TRIGGER ROTARY

    MDR report key: 3192570 · Received June 27, 2013

    Report

    Report Number
    0001811755-2013-01481
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    May 30, 2013
    Report Date
    June 3, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON VISUAL EVALUATION BY THE MANUFACTURER SERVICE TECHNICIAN, IT WAS CONFIRMED THAT THE FRONT END ASSEMBLY HAD METAL SHAVINGS. NO SPECIFIC DEVICE FAILURE WAS IDENTIFIED, BUT BASED ON A REVIEW OF COMPLAINT TRENDING, A PROBABLE CAUSE FOR THE REPORTED EVENT IS WEAR OVER TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW UP WILL BE SUBMITTED ONCE QUALITY INVESTIGATION IS COMPLETE. (B)(4): FAILURE ANALYSIS IN PROGRESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY THE DEVICE WAS PRODUCING METAL SHAVINGS. THERE WAS NO REPORT OF THE METAL SHAVINGS ENTERING THE SURGICAL SITE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY THE DEVICE WAS PRODUCING METAL SHAVINGS. THERE WAS NO REPORT OF THE METAL SHAVINGS ENTERING THE SURGICAL SITE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294454 DUAL TRIGGER ROTARY INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT KIJ STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1