MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL PROTAPER H-U 21MM/F1 *NOT CE*; FILE, PULP CANAL, ENDODONTIC

Catalog Number	A041702110112
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
In this event it is reported that protaper h-u 21mm/f1 -not ce- rubber handle separated from the file.The file had to be extracted by forceps.Further information requested.
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.
Additional Manufacturer Narrative
Involved product whose the handle gets separated / loosened during use was not returned and cannot be analyzed.Nothing unusual to report was found during dhr review (batch #1710737).The records of the torque tests performed during manufacturing process are available and instruments were found in compliance with iso 3630-1 standard requirements.No unused file was returned for additional evaluation.Root causes are not identified.We will track this kind of event and monitor the trend.Potential root causes may be incorrect technique (hand used file - technique no more verifiable to date), overuse (number of uses not communicated), excessive wear, patient condition and behaviour during treatment or material issue (no analysis of the file 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.In addition, protaper instruments must be still used passively into the canal.

• 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: 21926079
• Report Number: 8031010-2025-00065
• Device Sequence Number: 12940325
• Product Code: EKS
• UDI-Device Identifier: D716PTUHF1211
• UDI-Public: D716PTUHF1211
• 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): 05/05/2025

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: A041702110112
• Device Lot Number: 1710737
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/16/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/16/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/14/2021
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown