MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL PROTAPER NEXT ASS.X1/X2/X3 31; FILE, PULP CANAL, ENDODONTIC

Catalog Number	A08002319A003
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
In this event it is reported that a protaper next ass.X1/x2/x3 31 file broke during use.The outcome of this event is unknown as of this mdr.Further information requested.
Additional Manufacturer Narrative
There has been a previous report received where this malfunction resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event 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.
Additional Manufacturer Narrative
The investigation results for this complaint are: involved product that broke during use was not returned, and cannot be fully identified and analyzed.Moreover, no unused file is available for evaluation.Nothing unusual to report was found during dhr review (batch #1861656).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 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.
Additional Manufacturer Narrative
Update on investigation: summary: a protaper next nitifile x1 31mm was returned in loose.The file is broken at the base of the active part (fatigue).No material defect was found during analysis of the rupture pattern.No unused protaper next nitifile x1 31mm is available for evaluation.Nothing unusual to report was found during dhr review (batch #1861656 - assortment a08002319a003).Root causes are not identified.We will track this kind of event and monitor the trend.

• Brand Name: PROTAPER NEXT ASS.X1/X2/X3 31
• 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: 22142744
• Report Number: 8031010-2025-00092
• Device Sequence Number: 20613695
• Product Code: EKS
• UDI-Device Identifier: D716PTNAST311
• UDI-Public: D716PTNAST311
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 08/25/2025

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: A08002319A003
• Device Lot Number: 1861656
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/21/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/21/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 07/30/2025; 08/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown