BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 7 DUAL TRIGGER ROTARY

    MDR report key: 3192172 · Received June 27, 2013

    Report

    Report Number
    0001811755-2013-01477
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 11, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED, BUT THE EVALUATION HAS NOT YET BEGUN. ADDITIONAL INFORMATION MAY BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    DURING THE DEVICE EVALUATION, THE REPORTED EVENT OF LEAKING WAS DUPLICATED. IT WAS CONFIRMED THAT THE HANDPIECE HAD GREASE ON THE FRONT BEARING. THIS LIKELY OCCURRED DUE TO NON-RECOMMENDED CLEANING PROCEDURES.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293633 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