BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEGEND TELESCOPING ATTACHMENT TUBE

    MDR report key: 8739044 · Received June 27, 2019

    Report

    Report Number
    1625507-2019-00052
    Event Type
    Injury
    Date Received
    June 27, 2019
    Date of Event
    June 4, 2019
    Report Date
    July 24, 2019
    Manufacturer
    MDT POWERED SURGICAL SOLUTIONS
    Product Code
    HBB
    PMA / PMN Number
    K020069
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORT CONFIRMED. EVALUATION DETERMINED THAT THE TELESCOPING TUBE WAS RETURNED USED AND INTACT. SMALL METAL BALL WAS NOT RETURNED. SMALL METAL BALL THAT CAME OUT OF THE ATTACHMENT WAS AN INDICATION THAT MOST LIKELY ONE OR BOTH OF THE DISTAL BEARINGS IN THE TELESCOPING TUBE CAME APART.THE MOST LIKELY CAUSE OF FAILURE WAS THAT THE DISTAL BEARING(S) IN THE TT12C TELESCOPING TUBE THAT WAS RETURNED WERE AT THEIR END OF LIFE AND DID NOT SUPPORT THE TOOL ADEQUATELY, WHICH INDUCED TOOL TO FRACTURE.REPORT CONFIRMED FOR THE TOOL. IT WAS RETURNED FRACTURED (A040101) AND USED. BOTH PIECES WERE RETURNED.IT WAS NOTED THAT THE STEM SURFACE HAS DISCOLORATION, GALLING AND NECKING NEAR FRACTURE. FRACTURE FACE IS PLANAR AND PERPENDICULAR TO AXIS OF ROTATION, INDICATING FATIGUE IN BENDING. GALLING WAS CONSISTENT WITH THE METAL TRANSFER FROM BEARING INNER RACE TO TOOL FROM VIBRATION (A051208). MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CAN BE DRAWN. NO EVALUATION WAS PERFORMED, AS THE DEVICE WAS NOT RETURNED. IF THE DEVICE IS RETURNED IN THE FUTURE, PRODUCT ANALYSIS MAY BE PERFORMED. THE DEVICE USER MANUAL WARNINGS SECTION INCLUDES INSTRUCTIONS TO CHECK THE DEVICE FOR DAMAGE BEFORE USE. IF DAMAGE IS FOUND, THE DEVICE SHOULD NOT BE USED. THE PREVENTIVE MAINTENANCE/SERVICE MANUAL FOR THE LEGEND SYSTEM SPECIFIES SERVICE INTERVALS FOR DEVICES BASED ON THE HOSPITAL USAGE LEVEL. THE MAXIMUM SPECIFIED SERVICE INTERVAL IS 24 MONTHS. DEVICE HAS BEEN IN USE FOR APPROXIMATELY 42 MONTHS WITH NO RECORD OF FACTORY SERVICE DURING THIS PERIOD. WE WILL CONTINUE TO TRACK AND TREND THIS COMPLAINT TYPE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TOOL WAS BROKEN DURING SURGERY. WHEN A NEW TOOL WAS PUT ON, A SMALL METAL BALL CAME OUT OF THE ATTACHMENT AND THERE WAS A POSSIBILITY THAT THE BALL BEARING REMAINED IN PATIENT'S BODY. THERE WAS ALSO A DELAY ON THE PROCEDURE WHEN THE TOOL CANNOT BE INSERTED INTO THE TELESCOPING TUBE. ON FOLLOW UP, IT WAS REPORTED THAT THE PATIENT UNDERWENT MRI TO CONFIRM IF THERE WERE ANY BROKEN PIECE INSIDE PATIENT'S BODY AND NO BROKEN PARTS WERE FOUND. THE HOSPITAL IS REQUESTING DEVICE EVALUATION TO CHECK IF THE BALLS BEARINGS IN THE ATTACHMENT ARE STILL COMPLETE. IF THE NUMBER DOES NOT MATCH, THERE IS A POSSIBILITY THAT THE BROKEN PIECES WERE LEFT IN THE PATIENT¿S BODY. IT WAS CONFIRMED THAT THERE WAS NO REVISION SURGERY AND THERE WAS NO HEALTH DAMAGE ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534231 LEGEND TELESCOPING ATTACHMENT TUBE MOTOR, DRILL, PNEUMATIC HBB MDT POWERED SURGICAL SOLUTIONS TT12C

    Patients

    Seq Age Sex Outcome Treatment
    1 Other T12MH30D: H5479023.| T12MH30D: H5479023