BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HENRY SCHEIN

    MDR report key: 23219502 · Received October 6, 2025

    Report

    Report Number
    3003444492-2024-00004
    Event Type
    Malfunction
    Date Received
    October 6, 2025
    Date of Event
    November 25, 2024
    Report Date
    November 29, 2024
    Manufacturer
    PRIMA DENTAL GROUP
    Product Code
    EJL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTING CRITERIA A: AN EVENT HAS OCCURRED - YES, THE DEVICE BROKE IN USE. REPORTING CRITERIA B: THE MANUFACTURER'S DEVICE IS SUSPECTED TO BE A CONTRIBUTORY CAUSE OF THE INCIDENT- YES. REPORTING CRITERIA C: THE EVENT LED, OR MIGHT HAVE LED, TO ONE OF THE FOLLOWING OUTCOMES: DEATH OF A PATIENT, USER OR OTHER PERSON; SERIOUS DETERIORATION IN STATE OF HEALTH OF A PATIENT, USER OR OTHER PERSON.- YES, DEVICE BROKE INSIDE PATIENT'S ORAL CAVITY DURING USE WHICH COULD HAVE LEAD TO PATIENT HARM, THEREFORE AN INITIAL REPORT HAS BEEN RAISED TO FDA MEDWATCH UNDER REFERENCE NUMBER (B)(4). PENDING ADDITIONAL INFORMATION FROM DISTRIBUTOR HOWEVER FOR PRECAUTIONARY MEASURES AN INITIAL REPORT WAS RAISED. INVESTIGATION/ROOT CAUSE: INVESTIGATION HAS SHOWED THAT THE INCORRECT POSITION OF THE BUR IN THE LOAD TEST MACHINE CAUSED A FAILURE IN THE LOAD TEST. CORRECTIVE ACTIONS: CHECK AND FIX THE INCORRECT BUR POSITION IN THE LOAD TEST MACHINE. ADD CHECK IN THE MAINTENANCE SCHEDULE. CHECK FOR EFFECTIVENESS: NO COMPLAINT HAS BEEN REGISTERED FOR THE SAME FAILURE MODE SINCE THE IMPLEMENTATION OF THE CORRECTIVE ACTIONS. THEREFORE, THE CORRECTIVE ACTIONS ARE CONSIDERED EFFECTIVE.

    Additional Manufacturer Narrative · 0

    REPORTING CRITERIA A: AN EVENT HAS OCCURRED - YES, THE DEVICE BROKE IN USE. REPORTING CRITERIA B: THE MANUFACTURER'S DEVICE IS SUSPECTED TO BE A CONTRIBUTORY CAUSE OF THE INCIDENT- YES. REPORTING CRITERIA C: THE EVENT LED, OR MIGHT HAVE LED, TO ONE OF THE FOLLOWING OUTCOMES: DEATH OF A PATIENT, USER OR OTHER PERSON; SERIOUS DETERIORATION IN STATE OF HEALTH OF A PATIENT, USER OR OTHER PERSON.- YES, DEVICE BROKE INSIDE PATIENT'S ORAL CAVITY DURING USE WHICH COULD HAVE LEAD TO PATIENT HARM, THEREFORE AN INITIAL REPORT HAS BEEN RAISED TO FDA MEDWATCH UNDER REFERENCE NUMBER (B)(4). PENDING ADDITIONAL INFORMATION FROM DISTRIBUTOR HOWEVER FOR PRECAUTIONARY MEASURES AN INITIAL REPORT WAS RAISED.

    Description of Event or Problem · 0

    HENRY SCHEIN INC - CONTROL NUMBER (B)(4) - ORAL SURGERY BUR SHANK 3 US_(B)(4)- CROUND023HL - LOT: 1568537 2029-06-20 - BUR BROKE IN PATIENT'S MOUTH, BROKEN PIECES RETRIEVED SAFELY. THE CUSTOMER WAS PERFORMING THEIR DENTAL PROCEDURE ON A 40-YEAR-OLD FEMALE PATIENT WHEN THE BUR BROKE IN THEIR MOUTH. THE DENTIST WAS ABLE TO RETRIEVE THE BROKEN PIECE(S) SAFELY. THE CUSTOMER WAS USING THEIR STRAUMANN HANDPIECE (NOT PURCHASED THROUGH HENRY SCHEIN), SN # (B)(6). THERE WAS NO PATIENT INJURY AND NO MEDICAL ATTENTION WAS NEEDED. THEY WERE UNABLE TO CONFIRM THE RPM USED. THEY FOLLOW A NORMAL STERILIZATION PROCESS WITH THEIR MIDMARK STEAM STERILIZER TO STERILIZE THEIR BURS AND FOLLOW THE PRODUCTS IFU STEP BY STEP. THIS HAS BEEN HAPPENING FOR THE PAST MONTH.

    Description of Event or Problem · 0

    (B)(6) - CONTROL NUMBER 123422 - ORAL SURGERY BUR SHANK 3 (B)(6) - CROUND023HL - LOT: 1568537 2029-06-20 - BUR BROKE IN PATIENT'S MOUTH, BROKEN PIECES RETRIEVED SAFELY. THE CUSTOMER WAS PERFORMING THEIR DENTAL PROCEDURE ON A 40-YEAR-OLD FEMALE PATIENT WHEN THE BUR BROKE IN THEIR MOUTH. THE DENTIST WAS ABLE TO RETRIEVE THE BROKEN PIECE(S) SAFELY. THE CUSTOMER WAS USING THEIR STRAUMANN HANDPIECE (NOT PURCHASED THROUGH HENRY SCHEIN), SN # (B)(6). THERE WAS NO PATIENT INJURY AND NO MEDICAL ATTENTION WAS NEEDED. THEY WERE UNABLE TO CONFIRM THE RPM USED. THEY FOLLOW A NORMAL STERILIZATION PROCESS WITH THEIR MIDMARK STEAM STERILIZER TO STERILIZE THEIR BURS AND FOLLOW THE PRODUCTS IFU STEP BY STEP. THIS HAS BEEN HAPPENING FOR THE PAST MONTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1650888 HENRY SCHEIN ORAL SURGERY BUR SHANK 3_1125603 - CROUND023HL EJL PRIMA DENTAL GROUP ORAL SURGERY BUR SHANK 3 1568537

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female