BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 5 RECIPROCATING SAW

    MDR report key: 4952639 · Received July 30, 2015

    Report

    Report Number
    0001811755-2015-02772
    Event Type
    Malfunction
    Date Received
    July 30, 2015
    Date of Event
    July 2, 2015
    Report Date
    May 25, 2017
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED AT THE MANUFACTURER FOR TESTING. AN EVALUATION WILL BE CONDUCTED UPON RECEIPT OF THE DEVICE, AND A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER THE QUALITY INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: DEVICE NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING ROUTINE MAINTENANCE CONDUCTED BY A MANUFACTURER FIELD SERVICE TECHNICIAN AT THE USER FACILITY THAT THE HANDPIECE WAS SLOW TO STOP AFTER THE TRIGGER WAS RELEASED. THERE WAS NO ASSOCIATED PROCEDURE. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING ROUTINE MAINTENANCE CONDUCTED BY A MANUFACTURER FIELD SERVICE TECHNICIAN AT THE USER FACILITY THAT THE HANDPIECE WAS SLOW TO STOP AFTER THE TRIGGER WAS RELEASED. THERE WAS NO ASSOCIATED PROCEDURE. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497720 SYSTEM 5 RECIPROCATING SAW INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT KIJ STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1