BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 7 RECIP SAW

    MDR report key: 2911284 · Received January 11, 2013

    Report

    Report Number
    0001811755-2013-00006
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 27, 2012
    Report Date
    December 27, 2012
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HAW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS IS IN PROGRESS; ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETED. FAILURE ANALYSIS IS IN PROGRESS; ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    IT WAS NOTED DURING FAILURE ANALYSIS THAT THERE WAS CORROSION IN THE TRIGGER ASSEMBLY, THIS CAN RESULT IN RUN-ON, HOWEVER NO RUN-ON WAS OBSERVED. THIS LIKELY OCCURRED DUE TO NOT FOLLOWING RECOMMENDED CLEANING AND STERILIZATION METHODS.

    Description of Event or Problem · 1

    THE SYSTEM 7 RECIPROCATING SAW WAS SENT FOR EVALUATION DUE TO RUNNING ON ITS OWN DURING A ROUTINE FIELD SERVICE MAINTENANCE VISIT. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE DEVICE.

    Description of Event or Problem · 1

    THE SYSTEM 7 RECIPROCATING SAW WAS SENT FOR EVALUATION DUE TO RUNNING ON ITS OWN DURING A ROUTINE FIELD SERVICE MAINTENANCE VISIT. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19106 SYSTEM 7 RECIP SAW INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HAW STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1