BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSKELETON® TCS

    MDR report key: 6443756 · Received March 29, 2017

    Report

    Report Number
    3006340236-2017-00005
    Event Type
    Malfunction
    Date Received
    March 29, 2017
    Date of Event
    March 1, 2017
    Report Date
    May 4, 2017
    Manufacturer
    TITAN SPINE, LLC
    Product Code
    OVE
    PMA / PMN Number
    K151596
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE PRODUCTS' DEVICE HISTORY RECORDS WERE PERFORMED FOR THE SUBJECT DEVICES. THE REVIEW REVEALED THERE WERE NO ANOMALIES OR NON-CONFORMANCES GENERATED DURING THE MANUFACTURE OF THESE DEVICES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DEVICES PASSED INSPECTION AND WERE APPROVED FOR INITIAL USE. ENDOSKELETON® TCS INSTRUMENTS SETS CONTAIN AN ENDOSKELETON® TCS SCREW RESCUE EXTRACTOR (5210-1048). THIS INSTRUMENT IS DESIGNED TO BE USED TO EXTRACT BONE SCREWS THAT HAVE BEEN IMPLANTED IF THE SURGEON DETERMINED THE REMOVAL OF THE SCREW IS NECESSARY. THE SURGEON ELECTED TO USE THE TCS STRAIGHT DRIVER TO REMOVE THE BONE SCREW INSTEAD OF THE TCS SCREW RESCUE EXTRACTOR. THIS RESULTED IN THE DISTAL TIP OF THE DRIVER BEING DAMAGED. HOWEVER, THE SURGEON WAS SUCCESSFULLY ABLE TO REMOVE THE BONE SCREWS. DUE TO THE EXPLANTED BONE SCREWS BEING DISPOSED OF AT STERILE PROCESSING, FURTHER INVESTIGATION ON THESE DEVICES COULD NOT BE PERFORMED TO DETERMINE THE ROOT CAUSE OF THE INCIDENT. THE LIKELY CAUSE OF THIS INCIDENT IS THE BONE SCREWS WERE INSERTED AT AN IMPROPER ANGLE. THE SALES REPRESENTATIVE REPORTED THE TCS CURVED AWL AND AWL GUIDE WAS USED TO CREATE THE PILOT HOLE. THIS COULD BE CAUSED BY THE SURGEON NOT PLACING THE AWL GUIDE IN THE OPTIMUM POSITION IN CREATING THE PILOT HOLE AS THE CURRENT INSTRUMENT DESIGN DID NOT ALLOW FOR AN ACCURATE PLACEMENT OF PILOT HOLE. THE CUP DESIGN IS A TAPER TO TAPER FIT WHICH DOES ALLOW SOME TOGGLING. A REPORT ADDENDUM WAS COMPLETED THAT SHOWED THE VISUAL DEPICTION OF SHAFT ANGLES POSSIBLY INTERFERING WITH ANATOMY. NEW AWL GUIDES (ENDOSKELETON® TCS BAYONETTED AWL GUIDE, 2.5MM AND 2.0MM) ARE BEING INTRODUCED INTO ENDOSKELETON® TCS INSTRUMENT SETS. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE PRODUCTS' DEVICE HISTORY RECORDS WERE PERFORMED FOR THE SUBJECT DEVICES. THE REVIEW REVEALED THERE WERE NO ANOMALIES OR NON-CONFORMANCES GENERATED DURING THE MANUFACTURE OF THESE DEVICES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DEVICES PASSED INSPECTION AND WERE APPROVED FOR INITIAL USE. ENDOSKELETON® TCS INSTRUMENTS SETS CONTAIN AN ENDOSKELETON® TCS SCREW RESCUE EXTRACTOR (5210-1048). THIS INSTRUMENT IS DESIGNED TO BE USED TO EXTRACT BONE SCREWS THAT HAVE BEEN IMPLANTED IF THE SURGEON DETERMINED THE REMOVAL OF THE SCREW IS NECESSARY. THE SURGEON ELECTED TO USE THE TCS STRAIGHT DRIVER TO REMOVE THE BONE SCREW INSTEAD OF THE TCS SCREW RESCUE EXTRACTOR. THIS RESULTED IN THE DISTAL TIP OF THE DRIVER BEING DAMAGED. HOWEVER, THE SURGEON WAS SUCCESSFULLY ABLE TO REMOVE THE BONE SCREWS. DUE TO THE EXPLANTED BONE SCREWS BEING DISPOSED OF AT STERILE PROCESSING, FURTHER INVESTIGATION ON THESE DEVICES COULD NOT BE PERFORMED TO DETERMINE THE ROOT CAUSE OF THE INCIDENT. THE LIKELY CAUSE OF THIS INCIDENT IS THE BONE SCREWS WERE INSERTED AT AN IMPROPER ANGLE. THE SALES REPRESENTATIVE REPORTED THE TCS CURVED AWL AND AWL GUIDE WAS USED TO CREATE THE PILOT HOLE. THIS COULD BE CAUSED BY THE SURGEON NOT PLACING THE AWL GUIDE IN THE OPTIMUM POSITION IN CREATING THE PILOT HOLE AS THE CURRENT INSTRUMENT DESIGN DID NOT ALLOW FOR AN ACCURATE PLACEMENT OF PILOT HOLE. NEW AWL GUIDES (ENDOSKELETON® TCS BAYONETTED AWL GUIDE, 2.5 MM AND 2.0 MM) ARE BEING INTRODUCED INTO ENDOSKELETON® TCS INSTRUMENT SETS. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    SURGEON HAD A FREE SPINNING LOCKING SCREW 5302-2514 (V20). SURGEON WAS ABLE TO UTILIZE STRAIGHT SCREW DRIVER 5210-1004 (L161101) TO MANIPULATE THE SCREW AND REMOVE IT. IN THE PROCESS, THE DISTAL TIP OF THE DRIVER (5210-1004) WAS MANGLED. IN ADDITION, THIS SCREW WAS REPLACED WITH ANOTHER SCREW THAT WAS NON-LOCKING 5301-3514 (V09). HOWEVER, SURGEON FELT THE SCREW HAD POOR PURCHASE AND REPLACED THIS SCREW WITH A 5301-3514 (V11). THE WHOLE INCIDENT CAUSED LESS THAN A 5-MINUTE DELAY AND PROVIDED NO HARM TO THE PATIENT. PATIENT IS DOING WELL AFTER THE COMPLETION OF THE SURGERY (AS FAR AS THE SALES REPRESENTATIVE WAS AWARE OF). THE SCREWS WERE DISPOSED OF AT STERILE PROCESSING

    Description of Event or Problem · 1

    SURGEON HAD A FREE SPINNING LOCKING SCREW 5302-2514 (V20). SURGEON WAS ABLE TO UTILIZE STRAIGHT SCREW DRIVER 5210-1004 (L161101) TO MANIPULATE THE SCREW AND REMOVE IT. IN THE PROCESS, THE DISTAL TIP OF THE DRIVER (5210-1004) WAS MANGLED. IN ADDITION, THIS SCREW WAS REPLACED WITH ANOTHER SCREW THAT WAS NON-LOCKING 5301-3514 (V09). HOWEVER, SURGEON FELT THE SCREW HAD POOR PURCHASE AND REPLACED THIS SCREW WITH A 5301-3514 (V11). THE WHOLE INCIDENT CAUSED LESS THAN A 5-MINUTE DELAY AND PROVIDED NO HARM TO THE PATIENT. PATIENT IS DOING WELL AFTER THE COMPLETION OF THE SURGERY (AS FAR AS THE SALES REPRESENTATIVE WAS AWARE OF). THE SCREWS WERE DISPOSED OF AT STERILE PROCESSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223889 ENDOSKELETON® TCS 3.5MM DIA, LOCKING BONE SCREW, 14MM OVE TITAN SPINE, LLC 5302-3514 V20

    Patients

    Seq Age Sex Outcome Treatment
    1