BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 7 RECIP SAW

    MDR report key: 3080178 · Received April 26, 2013

    Report

    Report Number
    0001811755-2013-00907
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 11, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF AN UNKNOWN SUBSTANCE ON THE LOANER DEVICE WAS NOT CONFIRMED. DURING THE FUNCTIONAL INSPECTION THERE WAS NO ACTIVE LEAKING OBSERVED AND NO SYMPTOM FAILURES WERE IDENTIFIED. THE HANDPIECE WAS OBSERVED TO PERFORM AND APPEAR AS DESIGNED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM 7 RECIP SAW WAS ALLEGEDLY LEAKING AN UNKNOWN SUBSTANCE UPON RECEIPT OF THE LOANER UNIT. 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 RECIP SAW WAS ALLEGEDLY LEAKING AN UNKNOWN SUBSTANCE UPON RECEIPT OF THE LOANER UNIT. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182105 SYSTEM 7 RECIP SAW INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1