BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVIO BONE SCREW DRIVER

    MDR report key: 6078540 · Received November 4, 2016

    Report

    Report Number
    3010266064-2016-00002
    Event Type
    Injury
    Date Received
    November 4, 2016
    Date of Event
    October 25, 2016
    Report Date
    August 19, 2020
    Manufacturer
    BLUE BELT TECHNOLOGIES
    Product Code
    OLO
    PMA / PMN Number
    K191223
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD REPORT DETAILING THE INCIDENT WAS EVALUATED, PATIENT X-RAYS WERE ALSO OBTAINED FOR REVIEW, AND THE PORTION OF THE BONE SCREW THAT WAS REMOVABLE WAS RETURNED TO THE MANUFACTURER. AFTER COMPLETION OF THE INVESTIGATION, IT WAS CONFIRMED THAT THE BONE SCREW WAS BENT DUE TO ITS PROXIMITY TO THE IMPLANT, WHEN PLACED. WHEN THE TOTAL KNEE TIBIAL IMPLANT COMPONENT WAS PLACED, THE KEEL THAT DESCENDS INTO THE TIBIA WENT FAR ENOUGH TO INTERSECT WITH THE BONE SCREW, BENDING IT IN PLACE. WHEN THE SCEW WAS REMOVED AFTER THE CASE WAS COMPLETED, THE TORSION FROM THE DRILL BROKE THE SCREW AT THE BENDING POINT, LEAVING THE TIP INSIDE THE PATIENT'S TIBIA. THE OVERALL CAUSE OF THIS SCENARIO WAS THE SURGEON'S PLACEMENT OF THE BONE SCREW BEING TOO FAR SUPERIOR AGAINST THE INSTRUCTIONS FOR USE AND TRAINING ADMINISTERED FOR PROPER PLACEMENT OF BONE TRACKING HARDWARE. THE CLINICAL REPRESENTATIVE PRESENT DURING THE CASE INDICATED THAT THE SURGEON WAS TRYING TO PLACE THE SCREWS WITHIN THE SURGICAL INCISION, WHICH IS NOT HIS COMMON PRACTICE AND IS IN CONTRADICTION WITH THE INSTRUCTIONS FOR USE AND TRAINING HE RECEIVED FOR PROPER PLACEMENT OF BONE SCREWS. THE X-RAY SHOWS THAT THE REMAINING PORTION OF THE BONE SCREW IS COMPLETELY CAPTIVATED WITHIN THE TIBIA -- NO PROTRUSION FROM THE BONE -- AND THE SURGEON DOES NOT FORESEE ANY PATIENT CONCERNS DUE TO ITS LOCATION. A CAPA HAS BEEN OPENED INTERNALLY TO DETERMINE THE NEED FOR ANY FURTHER ACTIONS THAT MAY NEED TO BE TAKEN ON THE PART OF THE MANUFACTURER TO EMPHASIZE TO USERS THE IMPORTANCE OF ADHERING TO INSTRUCTIONS FOR USE FOR PROPER PLACEMENT OF BONE SCREWS.

    Additional Manufacturer Narrative · 0

    H10: H3, H6: THE REPORTED DEVICE, USED FOR TREATMENT, WAS NOT RETURNED TO THE DESIGNATED COMPLAINT UNIT FOR INDEPENDENT EVALUATION. INTERVIEW WITH A SITE REPRESENTATIVE DETERMINED THAT THE BONE PIN WAS BENT DUE TO ITS PROXIMITY TO THE IMPLANT. WHEN THE SCREW WAS REMOVED AFTER THE CASE THE TORSION FROM THE DRILL BROKE THE SCREW AT THE BENDING POINT, LEAVING THE TIP INSIDE THE PATIENT'S TIBIA. REVIEW OF X-RAYS PROVIDED BY THE SITE WAS PERFORMED AND CONFIRMED THE REMAINING PORTION OF THE BONE SCREW WAS COMPLETELY ENCAPSULATED IN PATIENT'S BONE. THE SURGEON DID NOT FORESEE ANY FUTURE ISSUES DUE TO ITS LOCATION. THIS FAILURE MODE IS IDENTIFIED WITHIN THE RISK ASSESSMENT. A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION OR WOULD NOT BE ABLE TO PERFORM AS INTENDED. A COMPLAINT HISTORY REVIEW IDENTIFIED SIMILAR EVENT THE NAVIO SYSTEM FOR UNICONDYLAR KNEE REPLACEMENT (UKR) USER'S MANUAL RELEASED AT THE TIME OF THE COMPLAINT PROVIDES DETAILED INSTRUCTIONS FOR PLACING THE BONE PINS AND TRACKER ARRAYS. WE WERE ABLE TO CONFIRM THERE WAS A RELATIONSHIP ESTABLISHED BETWEEN THE REPORTED EVENT AND THE DEVICE. THE MALFUNCTION WAS LIKELY DUE TO USER ERROR OF THE PLACEMENT OF THE BONE PIN'S PROXIMITY TO THE IMPLANT. WHEN THE TIBIAL IMPLANT WAS PLACED THE KEEL THAT DESCENDED INTO THE TIBIA WENT FAR ENOUGH TO INTERSECT WITH THE BONE SCREW, BENDING IT IN PLACE. WHEN THE SCREW WAS REMOVED AFTER THE CASE THE TORSION FROM THE DRILL BROKE THE SCREW AT THE BENDING POINT, LEAVING THE TIP INSIDE THE PATIENT'S TIBIA.

    Additional Manufacturer Narrative · 1

    WE BELIEVE, UPON INITIAL REVIEW OF THE INCIDENT, THAT THE SURGEON PLACED THE BONE SCREW TOO CLOSE TO THE JOINT AND DID NOT FOLLOW THE INSTRUCTIONS FOR USE AS TO PROPER PLACEMENT OF THE BONE SCREWS. BY PLACING THE BONE SCREW TOO CLOSE TO THE JOINT, IT CAME INTO CONTACT WITH THE TIBIAL COMPONENT FIXATION FEATURE WHEN THE TIBIAL COMPONENT WAS IMPACTED INTO THE BONE. THIS BENT THE BONE SCREW, CAUSING THE PIECE BELOW THE BEND TO BREAK OFF WHEN THE BONE SCREW WAS REMOVED. THE BROKEN TIP WAS THEREFORE LEFT RETAINED IN THE TIBIA. THERE WAS NO WAY FOR THE SURGEON TO RETRIEVE THE BROKEN PIECE. THE SURGEON DETERMINED THAT IT WAS ACCEPTABLE TO LEAVE THE PIECE OF BONE SCREW IN THE PATIENT'S TIBIA. BLUE BELT TECHNOLOGIES IS WAITING TO RECEIVE THE REST OF THE BONE SCREW THAT WAS REMOVED FOR ADDITIONAL EVALUATION.

    Description of Event or Problem · 1

    SURGEON DID NOT FOLLOW INSTRUCTIONS FOR USE. PLACED BONE SCREW TOO CLOSE TO THE INCISION SITE. UNKNOWN TO THE SURGICAL TEAM, WHEN PLACING THE TIBIAL PROSTHESIS, THE FIXATION FEATURE ON THE TIBIAL PROSTHESIS CAME IN CONTACT WITH THE BONE SCREW PLACED IN THE TIBIA, BENDING THE BONE SCREW. AT THE CONCLUSION OF THE SURGERY, THE SURGEON BEGAN TO REMOVE THE BONE SCREWS AND THE TIP OF THE BENT BONE SCREW BROKE OFF IN THE TIBIA AT THE POINT WHERE IT WAS BENT. THE BROKEN TIP OF THE BONE SCREW WAS IRRETRIEVABLE AND LEFT IN THE PATIENT'S TIBIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE SURGEON WAS IMPLANTING THE TIBIAL PROSTHESIS, ONE OF THE TIBIAL BONE PINS BENT. THIS WAS UNKNOWN TO EVERYONE. AS THE SURGEON TRIED TO TAKE THE PIN OUT, IT WAS CAUGHT BEHIND THE TIP OF THE TIBIAL IMPLANT AND THE TIP BROKE OFF. THE TIP COULD NOT BE REMOVED FROM THE PATIENT, IT WAS LEFT IN THE TIBIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    730614 NAVIO BONE SCREW DRIVER ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES NPFS02000

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention