MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL CARBIDE BUR CAVITY ROUND FG012; BUR, DENTAL

Catalog Number	E012334101200
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
While no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such.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 it is reported that a carbide bur cavity round fg012 bur broke during use.No injury occurred.
Additional Manufacturer Narrative
Additional information received: we received the following information regarding this complaint: before breaking, the file was disinfected and used 5 times.The customer has discarded the broken product, will not return.This is a follow up report for this additional information.Investigation results: summary: involved product that broke during use 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 #1772984).Root causes are not identified.We will track this kind of event and monitor the trend.Potential root causes may be incorrect technique (motor setting not communicated), overuse (bur used five times - multiple reuses may increase risks of breakage), excessive wear (bur used five times), or material issue (no analysis of the broken fragments 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.

• Brand Name: CARBIDE BUR CAVITY ROUND FG012
• Common Device Name: BUR, DENTAL
• 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: 23542430
• Report Number: 8031010-2025-00205
• Device Sequence Number: 9719307
• Product Code: EJL
• UDI-Device Identifier: J003E0123341012001
• UDI-Public: J003E0123341012001
• 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): 12/09/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: E012334101200
• Device Lot Number: 1772984
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/07/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/07/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown