BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 7 DUAL TRIGGER ROTARY

    MDR report key: 3192155 · Received June 27, 2013

    Report

    Report Number
    0001811755-2013-01473
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 5, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE DEVICE EVALUATION, THE REPORTED EVENT OF LEAKING WAS NOT DUPLICATED. HOWEVER, IT WAS CONFIRMED THAT THE HANDPIECE HAD CORROSION. FLUID TRAPPED INSIDE HANDPIECES DUE TO IMPROPER CLEANING AND STERILIZATION METHODS THAT IS LATER OBSERVED LEAKING OUT CAN RESULT IN CORROSION DUE TO PROLONGED EXPOSURE TO THE HANDPIECE. CLEANING PRACTICES USED AT THE ACCOUNT LIKELY CAUSED OR CONTRIBUTED TO THE CORROSION FOUND.

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS IS ONGOING; ADDITIONAL INFORMATION MAY BE SUBMITTED ONCE THE RESULTS ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM 7 DUAL TRIGGER ROTARY WAS ALLEGEDLY LEAKING AN UNKNOWN SUBSTANCE DURING TESTING/INSPECTION. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM 7 DUAL TRIGGER ROTARY WAS ALLEGEDLY LEAKING AN UNKNOWN SUBSTANCE DURING TESTING/INSPECTION. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291908 SYSTEM 7 DUAL TRIGGER ROTARY INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1