BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TROCAR HANDLE, LONG, ICON

    MDR report key: 17284986 · Received July 9, 2023

    Report

    Report Number
    2027754-2023-00026
    Event Type
    Injury
    Date Received
    July 9, 2023
    Date of Event
    June 27, 2023
    Report Date
    July 21, 2023
    Manufacturer
    OSTEOMED, LLC
    Product Code
    JEY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS CURRENTLY PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED A MINOR BURN ON THE PATIENT'S LIP OCCURRED WITH THE USE OF POWER DEVICE(S) AND THE PART NUMBER 220-0851 TROCAR HANDLE LONG, ICON. NO DEVICE COMPONENTS WERE RECEIVED FOR EVALUATION. FOUR (4) POSSIBLE LOT NUMBERS FOR THE TROCAR HANDLE WERE PROVIDED; HOWEVER, IT IS UNKNOWN WHICH LOT NUMBER CORRESPONDS TO THE COMPLAINT DEVICE. REVIEW OF THE DEVICE HISTORY RECORDS (DHR) OF ALL FOUR (4) POSSIBLE LOT NUMBERS REVEALED ALL INSPECTIONS PASSED WITH NO ANOMALIES IDENTIFIED. A REVIEW OF THE COMPLAINT DATABASE FOR PART NUMBER 220-0851 INDICATED ONE (1) COMPLAINT IN A TWO-YEAR PERIOD, WHICH IS THE COMPLAINT IN THIS REPORT. A TWO-YEAR REVIEW OF THE COMPLAINT DATABASE FOR "BURN" REVEALED ONE ADDITIONAL COMPLAINT (FOR A DIFFERENT PART NUMBER). ADDITIONAL INTERVIEW/DISCUSSION REGARDING THE REPORTED EVENT INDICATED THE TROCAR WAS AGAINST THE PATIENT'S LIP POTENTIALLY AS THOUGH IT WAS BEING USED LIKE A CHEEK RETRACTOR. THE FOLLOWING STATEMENTS ARE IN THE INSTRUCTIONS FOR USE: "THE SURGEON SHOULD HAVE SPECIFIC TRAINING, EXPERIENCE, AND THOROUGH FAMILIARITY WITH THE USE OF RIGID FIXATION PRODUCTS AND TECHNIQUES." "CAREFULLY INSPECT THE OSTEOMED IMPLANTS PRIOR TO USE. INSPECT THE INSTRUMENTS BEFORE AND AFTER EACH PROCEDURE TO ASSURE THEY ARE IN PROPER OPERATING CONDITION. INSTRUMENTS WHICH ARE FAULTY, DAMAGED, OR SUSPECT SHOULD NOT BE USED. THEY SHOULD BE REPLACED OR SENT TO OSTEOMED FOR DISPOSITION AND REPAIR." "CANNULA IS NEVER TO BE USED AS A CHEEK RETRACTOR WHEN DRILLING." "WHEN USING THE DRILL GUIDE, DO NOT APPLY A SIDE LOAD ON THE DRILL. THIS MAY RESULT IN FRICTION, WHICH MAY GENERATE A THERMAL BURN. AXIAL LOADING SHOULD ALWAYS BE USED." "WHEN USING THE TRANSBUCCAL APPROACH, ENSURE CHEEK RETRACTOR IS USED TO PROTECT SOFT TISSUE." THEREFORE, BASED ON THE INFORMATION RECEIVED AND THE INVESTIGATION PERFORMED, THE ROOT CAUSE IS FAILURE TO FOLLOW INSTRUCTIONS. CORRECTION: CODING IN H10 UPDATED/CHANGED: MEDICAL DEVICE PROBLEM CODE (ANNEX A) CHANGED TO 2017- IMPROPER OR INCORRECT PROCEDURE OR METHOD. ADDITION OF 4111-COMMUNICATION/INTERVIEWS TO TYPE OF INVESTIGATION (ANNEX B). INVESTIGATION FINDINGS (ANNEX C) CHANGED TO 4248- USAGE PROBLEM IDENTIFIED. INVESTIGATION CONCLUSION (ANNEX D) CHANGED TO 18- FAILURE TO FOLLOW INSTRUCTIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING DRILLING WHILE USING THE PART NUMBER 220-0851 TROCAR HANDLE, LONG, ICON DEVICE, A MINOR BURN TO THE PATIENT'S LIP OCCURRED. ALSO, IT WAS ALSO REPORTED THAT NO FURTHER INTERVENTION TO THE PATIENT WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168977 TROCAR HANDLE, LONG, ICON PLATE, BONE JEY OSTEOMED, LLC 220-0851

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other