BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAGITTAL SAW ATTACHMENT

    MDR report key: 3172975 · Received June 17, 2013

    Report

    Report Number
    0001811755-2013-01391
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 22, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETE. H3 OTHER TEXT : THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE QUALITY INVESTIGATION HAS BEEN CLOSED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS. .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING EQUIPMENT TESTING CONDUCTED BY A MANUFACTURER FIELD SERVICE TECHNICIAN AT THE USER FACILITY THE DEVICE WAS OVERHEATING. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING EQUIPMENT TESTING CONDUCTED BY A MANUFACTURER FIELD SERVICE TECHNICIAN AT THE USER FACILITY THE DEVICE WAS OVERHEATING. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273721 SAGITTAL SAW ATTACHMENT INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1