BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEDFUSE RESET DRIVER

    MDR report key: 3012556 · Received March 15, 2013

    Report

    Report Number
    3005977257-2013-00012
    Event Type
    Injury
    Date Received
    March 15, 2013
    Date of Event
    February 15, 2013
    Report Date
    March 15, 2013
    Manufacturer
    SPINEFRONTIER
    Product Code
    MNH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS GATHERED DURING A FOLLOW UP CONVERSATION WITH THE FIELD REPRESENTATIVE. THE SET HAD BEEN CLEANED AND STERILIZED AFTER SURGERY ON (B)(6) 2013 AND PRIOR TO THE SURGERY THAT WAS PLANNED FOR ON (B)(6) 2013. THE SET WAS THEN HAND DELIVERED BY A REPRESENTATIVE TO THE SECOND FACILITY WHERE IT WAS CLEANED AND STERILIZED AGAIN PRIOR TO SURGERY ON (B)(6) 2013. IT WAS DURING THE CLEANING AND STERILIZATION PROCESS AFTER SURGERY ON (B)(6) 2013 AT THE SECOND FACILITY THAT THE DRIED BLOOD WAS NOTED BY HOSPITAL PERSONNEL. THE REPRESENTATIVE WAS NOTIFIED ON (B)(6) 2013. IT IS UNKNOWN WHETHER THE DIRTY INSTRUMENT WAS USED DURING SURGERY ON (B)(6) 2013, AS MULTIPLE DRIVERS ARE INCLUDED IN EACH SET. PEDFUSE PACKAGE INSERT (DOC80019 REV. B P. 18) INCLUDES DETAILED INSTRUCTIONS FOR CLEANING AND STERILIZATION OF PRODUCT. FIELD REPRESENTATIVE REPORTED DURING FOLLOW UP CONVERSATION THAT THE INSTRUMENT HAD SINCE BEEN CLEANED, HOWEVER, A PHOTO HAD BEEN TAKEN BY HOSPITAL STAFF. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN A COPY OF THE PHOTO FOR SPINEFRONTIER RECORDS. IF WE ARE SUCCESSFUL IN OBTAINING THE PHOTO, THIS REPORT WILL BE AMENDED TO INCLUDE IT.

    Description of Event or Problem · 1

    ON (B)(6) 2013 A FIELD REPRESENTATIVE WAS NOTIFIED OF A DIRTY INSTRUMENT THAT MAY HAVE BEEN IN THE OPERATING ROOM DURING A SURGERY ON (B)(6) 2013. THE SET THAT THE INSTRUMENT WAS IN HAD BEEN USED IN A SURGERY ON (B)(6) 2013 AND WAS THEN CLEANED AND STERILIZED IN PREPARATION FOR A SURGERY ON (B)(6) 2013. THE SURGERY SCHEDULED FOR ON (B)(6) 2013 WAS CANCELLED AND THE SET WAS TRANSPORTED TO A SECOND FACILITY FOR USE ON (B)(6) 2013. AFTER SURGERY ON (B)(6) 2013, DURING CLEANING OF THE SET, HOSPITAL PERSONNEL NOTICED THAT THERE WAS OLD BLOOD (ASSUMED TO BE FROM A PRIOR SURGERY) ON THE INNER SHAFT OF THE PEDFUSE DRIVER. THEY ARE CONFIDENT THAT IT IS BLOOD FROM A PAST SURGERY BECAUSE IT WAS DRY AND CAKED ON THE DRIVER'S INNER SHAFT. NOTE TWO SURGERIES WERE CONDUCTED AT THE SECOND FACILITY ON (B)(6) 2013 USING THE PEDFUSE SYSTEM. IF THE DIRTY INSTRUMENT WAS USED IN THE OPERATING ROOM, EITHER PATIENT MAY HAVE BEEN AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110995 PEDFUSE RESET DRIVER PEDICLE SCREW DRIVER MNH SPINEFRONTIER 11-80111

    Patients

    Seq Age Sex Outcome Treatment
    1 Other