MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL DIAM.B.S.PREP.CONIC. FG M 010; INSTRUMENT, DIAMOND, DENTAL

Catalog Number	F016734201000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/26/2024
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 is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.
Event or Problem Description
In this event it is reported that a diam.B.S.Prep.Conic.Fg m 010 bur broke during use.The user does not know what happened to the broken part.It is assumed that they may have been swallowed.Further information requested.
Additional Manufacturer Narrative
Investigation: 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 #1876802).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 (number of uses not communicated), excessive wear, or material issue (no analysis of the broken fragments possible).Root causes are not identified.

• Brand Name: DIAM.B.S.PREP.CONIC. FG M 010
• Common Device Name: INSTRUMENT, DIAMOND, 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: 20872696
• Report Number: 8031010-2024-00159
• Device Sequence Number: 12969590
• Product Code: DZP
• UDI-Device Identifier: J003F0167342010001
• UDI-Public: J003F0167342010001
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 01/22/2025

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: F016734201000
• Device Lot Number: 1876802
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/29/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/29/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 01/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown