BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 7 V-NOTCH SAGITTAL SAW

    MDR report key: 3192165 · Received June 27, 2013

    Report

    Report Number
    0001811755-2013-01475
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    June 10, 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
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DURING THE DEVICE EVALUATION, THE REPORTED EVENT OF LEAKING WAS NOT CONFIRMED. NO FOREIGN MATERIAL OR EVIDENCE OF LEAKING WAS FOUND. THE HANDPIECE WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM 7 V-NOTCH SAGITTAL SAW WAS ALLEGEDLY LEAKING AN UNKNOWN SUBSTANCE DURING TESTING OR SETUP PRIOR TO THE PROCEDURE. 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 V-NOTCH SAGITTAL SAW WAS ALLEGEDLY LEAKING AN UNKNOWN SUBSTANCE DURING TESTING OR SETUP PRIOR TO THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291799 SYSTEM 7 V-NOTCH SAGITTAL SAW INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1