BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYS 6 RECIP

    MDR report key: 3234063 · Received July 18, 2013

    Report

    Report Number
    0001811755-2013-01693
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 26, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS AVAILABLE FOR EVALUATION BUT HAS NOT YET BEEN RECEIVED. ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE DEVICE IS RECEIVED AND THE QUALITY INVESTIGATION IS COMPLETE. THE DEVICE IS AVAILABLE FOR EVALUATION BUT HAS NOT YET BEEN RECEIVED. ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE DEVICE IS RECEIVED AND THE QUALITY INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE REPORTED OVERHEATING WAS CONFIRMED BY A MANUFACTURER SERVICE TECHNICIAN THROUGH FUNCTIONAL EVALUATION. UPON DISASSEMBLY, A MOTOR WINDING SHORT WAS IDENTIFIED AS THE PROBABLE CAUSE FOR THE REPORTED OVERHEATING. THE REPORTED EVENT OF THE DEVICE NOT HOLDING A BLADE WAS NOT CONFIRMED. NO FAILURES WERE IDENTIFIED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO BLADE FIT.

    Additional Manufacturer Narrative · 1

    OVERHEATING WAS DISCOVERED DURING TESTING AT THE MANUFACTURER FACILITY AND HAS BEEN ADDED TO THIS REPORT. THE DEVICE HAS BEEN RECEIVED AT THE MANUFACTURER FACILITY. 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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY THE DEVICE WOULD NOT RETAIN A BLADE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING BACK-UP EQUIPMENT WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED. DURING FUNCTIONAL TESTING BY A SERVICE TECHNICIAN AT THE MANUFACTURER FACILITY, IT WAS FOUND THAT THE DEVICE WAS OVERHEATING. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE MANUFACTURER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY THE DEVICE WOULD NOT RETAIN A BLADE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING BACK-UP EQUIPMENT WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY THE DEVICE WOULD NOT RETAIN A BLADE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING BACK-UP EQUIPMENT WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED. DURING FUNCTIONAL TESTING BY A SERVICE TECHNICIAN AT THE MANUFACTURER FACILITY, IT WAS FOUND THAT THE DEVICE WAS OVERHEATING. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE MANUFACTURER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335152 SYS 6 RECIP INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT KIJ STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1