MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL CARBIDE BUR CAVITY ROUND RA16; FILE, PULP CANAL, ENDODONTIC

Catalog Number	E012324101600
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As a result of this malfunction, the potential for surgical intervention exists to preclude permanent damage to a body structure or permanent impairment of a body function as evidenced by previous reported events with similar files.This event, therefore, is reportable per 21cfr part 803.The device was not returned for evaluation.However, the lot number was provided and retained-product testing and/or dhr review are planned.The results will be submitted as they become available.
Event or Problem Description
In this event a carbide bur cavity round ra16 used broke on a patient experienced pain following a treatment and repaired with caries, routine disinfection of iodophor intraoral and extraoral, routine towel laying, and local infiltration anesthesia with 4% articaine.After the onset of effect, the positioning drill is incised along the alveolar ridge crest, the flap is turned over, the caries tissue is removed, the encapsulation is restored, and the resin material is filled after 7 days.The symptoms were relieved by anti-inflammatory, analgesic, and dressing change in the hospital on the same day.
Additional Manufacturer Narrative
Summary: involved product that didn't give satisfaction was not returned and cannot be analyzed.Moreover, no unused bur is available for evaluation.Nothing unusual to report was found during dhr review (batch #1755858).Root causes are not identified.We will track this kind of event and monitor the trend.Potential root causes may be incorrect technique, overuse (number of uses not communicated), excessive wear, patient condition and behavior during treatment or material issue (no analysis of the bur possible).In addition, there are further circumstances on the conditions in dentistry (used disinfectants, training/knowledge status), or any other environmental conditions, which are unknown to us and may also have an impact on the reported failure mode.Additional information we received the following information regarding this complaint : sales forwarded the information as follow.1.Patient have bleeding and pain during the treatment process using bur, which is a normal phenomenon during the treatment process, and there is no adverse reaction after treatment.2.The patient has recovered without any discomfort.3.The product is not returned, will not return.This is a follow up report for this additional information.

• Brand Name: CARBIDE BUR CAVITY ROUND RA16
• Common Device Name: FILE, PULP CANAL, ENDODONTIC
• Manufacturer (Section D): MAILLEFER INSTRUMENTS HOLDING SARL; ch. du verger 3; ballaigues vaud CH-13 38; SZ CH-1338
• Manufacturer (Section G): MAILLEFER INSTRUMENTS HOLDING SARL; ch. du verger 3; ballaigues vaud CH-13 38; SZ CH-1338
• Manufacturer Contact: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 22360675
• Report Number: 8031010-2025-00105
• Device Sequence Number: 8655445
• Product Code: EKS
• UDI-Device Identifier: J003E0123241016001
• UDI-Public: J003E0123241016001
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: E012324101600
• Device Lot Number: 1755858
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/18/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/18/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/30/2025
• Supplement Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown