BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORE HEAVY DUTY POWER PACK

    MDR report key: 3080394 · Received April 26, 2013

    Report

    Report Number
    0001811755-2013-00921
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    January 28, 2013
    Report Date
    April 16, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HWE
    PMA / PMN Number
    K942956
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT WAS CONFIRMED. THE CABLE WAS FOUND TO BE SEVERED WITH THERMAL DAMAGE TO THE END OF THE CABLE. THE FAILURE OF THE CABLE WAS MOST LIKELY CAUSED BY REPEATED FLEXURE OF THE CABLE WHICH CAUSED THE M1 AND M2 SHIELD CONDUCTORS TO DEGRADE AND BREAK INSIDE THE CABLE. THE LACK OF CONTINUITY OF THE M1 AND M2 SHIELDS EFFECTIVELY DISABLED THE PROTECTIVE MECHANISM OF THE FUSE THAT CONNECTS THE SHIELDS AND CABLE SENSE TO CONSOLE GROUND. AS A RESULT, WHEN THE MOTOR WIRE INSULATION BROKE DOWN AT THE POWER PACK END, THE MOTOR WIRES WOULD HAVE SHORTED TO THE SHIELDS LOCALLY BUT SINCE THEY WERE NO LONGER CONNECTED TO THE FUSE, THE FUSE DID NOT OPEN AND DID NOT CAUSE CABLE SENSE TO LOSE GROUND. THE DESIGN INTENT IS FOR CABLE SENSE TO LOSE GROUND WHEN THE FUSE OPENS DUE TO M1-M2 SHORTING TO SHIELD WIRES AND PASSING ENOUGH CURRENT THROUGH THE FUSE TO CAUSE IT TO OPEN. SINCE THE FUSE DID NOT OPEN, THE CONSOLE CONTINUED TO SOURCE CURRENT TO THE MOTOR WIRES WHICH CAUSED THE CABLE TO BECOME HOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CORE HEAVY DUTY POWER PACK SPARKED A SMALL FLAME DURING A HÁLLUX VALGUS PROCEDURE. A SMALL AREA OF THE OPERATIVE FIELD WAS ALLEGEDLY BURNED, RESULTING IN A SECOND DEGREE BURN (APPROXIMATELY 3 CM IN LENGTH AND 2 CM IN DIAMETER) ON THE LEFT LEG OF THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CORE HEAVY DUTY POWER PACK SPARKED A SMALL FLAME DURING A HÁLLUX VALGUS PROCEDURE. A SMALL AREA OF THE OPERATIVE FIELD WAS ALLEGEDLY BURNED, RESULTING IN A SECOND DEGREE BURN (APPROXIMATELY 3 CM IN LENGTH AND 2 CM IN DIAMETER) ON THE LEFT LEG OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181365 CORE HEAVY DUTY POWER PACK INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1