BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 7 RECIP SAW

    MDR report key: 2911279 · Received January 11, 2013

    Report

    Report Number
    0001811755-2013-00007
    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
    HWE
    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 THE HANDPIECE HAD RUN-ON DUE TO CORROSION BUILT UP IN THE TRIGGER ASSEMBLY. 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 SERVICE BECAUSE DURING ROUTINE FIELD SERVICE MAINTENANCE VISIT THE DEVICE RAN ON ITS OWN WITHOUT USER ACTIVATION. 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 SERVICE BECAUSE DURING ROUTINE FIELD SERVICE MAINTENANCE VISIT THE DEVICE RAN ON ITS OWN WITHOUT USER ACTIVATION. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17975 SYSTEM 7 RECIP SAW INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1