BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 5 RECIPROCATING SAW

    MDR report key: 3970180 · Received July 31, 2014

    Report

    Report Number
    0001811755-2014-02732
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 4, 2014
    Report Date
    July 4, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE REPORTED BLADE RETENTION ISSUE WAS CONFIRMED BY A MANUFACTURER REPAIR TECHNICIAN THROUGH FUNCTIONAL EVALUATION. UPON DISASSEMBLY, CORROSION WAS FOUND THROUGHOUT THE MOTOR AND DRIVETRAIN, AND IT WAS FOUND THAT THE CHUCK AND YOKE ASSEMBLY WERE BENT, WHICH CAN LEAD TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING PRIOR TO A SURGICAL PROCEDURE AT THE USER FACILITY, THE DEVICE WOULD NOT RETAIN A BLADE. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING PRIOR TO A SURGICAL PROCEDURE AT THE USER FACILITY, THE DEVICE WOULD NOT RETAIN A BLADE. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448375 SYSTEM 5 RECIPROCATING SAW INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT KIJ STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1