BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SABO SAG SAW

    MDR report key: 3163388 · Received June 11, 2013

    Report

    Report Number
    0001811755-2013-01335
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 17, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HRX
    PMA / PMN Number
    K943323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    UPON EVALUATION BY A MANUFACTURER TECHNICIAN, THE FAILURE OF A BLADE BEING BROKEN OFF IN THE DEVICE WAS NOT CONFIRMED. THROUGH VISUAL INSPECTION, THE BOOT WAS FOUND TO BE RIPPED, ALTHOUGH IS NOT BELIEVED TO BE RELATED TO THE REPORTED EVENT. THE DEVICE WAS SERVICED AND RETURNED TO THE USER FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING STERILE PROCESSING AT THE USER FACILITY, A PIECE OF A CUTTING BLADE WAS STUCK IN THE BLADE MOUNT. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING STERILE PROCESSING AT THE USER FACILITY, A PIECE OF A CUTTING BLADE WAS STUCK IN THE BLADE MOUNT. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264177 SABO SAG SAW ARTHROSCOPE HRX STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN INSTRUMENTS BLADE, LOT # UNKNOWN