BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 6 SAGITTAL SAW

    MDR report key: 3121239 · Received May 20, 2013

    Report

    Report Number
    0001811755-2013-01154
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 8, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF A BROKEN SCREW WAS DUPLICATED. IT WAS CONFIRMED BY A MANUFACTURER SERVICE TECHNICIAN THAT THE LEVER ON THE BLADE MOUNT WAS BROKEN OFF THROUGH VISUAL EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING CLEANING AFTER A SURGICAL PROCEDURE AT THE USER FACILITY A SCREW AT THE BLADE MOUNT BROKE. 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 CLEANING AFTER A SURGICAL PROCEDURE AT THE USER FACILITY A SCREW AT THE BLADE MOUNT BROKE. 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
    222249 SYSTEM 6 SAGITTAL SAW INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT KIJ STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1