BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 5 RECIPROCATING SAW

    MDR report key: 3083743 · Received April 29, 2013

    Report

    Report Number
    0001811755-2013-00960
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 20, 2013
    Report Date
    April 20, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED, BUT THE EVALUATION HAS NOT YET BEGUN. ADDITIONAL INFORMATION MAY BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    DURING THE DEVICE EVALUATION, THE REPORTED EVENT OF SMOKING WAS CONFIRMED. UPON DISASSEMBLY IT WAS FOUND THAT THE HANDPIECE HAD NON-STRYKER COMPONENTS INCLUDING THE CONTROLLER WHICH WERE DETERMINED TO HAVE CAUSED THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING CONDUCTED BY A FIELD SERVICE TECHNICIAN, THE SYSTEM 5 RECIPROCATING SAW WAS SMOKING . THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, SO THERE WAS NO PATIENT INVOLVEMENT. NO USER INJURY WAS REPORTED, AND NO OTHER ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING CONDUCTED BY A FIELD SERVICE TECHNICIAN, THE SYSTEM 5 RECIPROCATING SAW WAS SMOKING . THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, SO THERE WAS NO PATIENT INVOLVEMENT. NO USER INJURY WAS REPORTED, AND NO OTHER ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183940 SYSTEM 5 RECIPROCATING SAW INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT KIJ STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1