BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SABO SAG SAW

    MDR report key: 2950531 · Received February 8, 2013

    Report

    Report Number
    0001811755-2013-00208
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 21, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION HAS BEEN PERFORMED.

    Additional Manufacturer Narrative · 1

    DURING THE DEVICE EVALUATION, THE MOTOR BEARINGS WERE FOUND TO BE DAMAGED AND SEIZED, WHICH IS A PROBABLE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY, THE SAW WAS RUNNING INTERMITTENTLY, WHICH CAUSED A 30 MINUTE DELAY TO THE PROCEDURE. NO MEDICAL INTERVENTION, NO ADDITIONAL ANESTHESIA DUE TO THE DELAY, AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY, THE SAW WAS RUNNING INTERMITTENTLY, WHICH CAUSED A 30 MINUTE DELAY TO THE PROCEDURE. NO MEDICAL INTERVENTION, NO ADDITIONAL ANESTHESIA DUE TO THE DELAY, AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54564 SABO SAG SAW INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT KIJ STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1