MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL PROGLIDER 6FILE STERILE 25MM; FILE, PULP CANAL, ENDODONTIC

Catalog Number	A092622500103
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Type of Reportable Event	Malfunction
Event or Problem Description
In this event it is reported that a proglider 6file sterile 25mm file broke during use.The broken part was not retrieved and is still in the root canal.No injury.
Additional Manufacturer Narrative
While no injury was reported, 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
Additional information; involved product that broke during use was not returned and cannot be analyzed.Moreover, no unused file is available for evaluation.Nothing unusual to report was found during dhr review (batch #1890630).Root causes are not identified.We will track this kind of event and monitor the trend.Potential root causes may be incorrect technique, overuse, 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
Additional information received for this complaint: has any patient been injured? no.Have all the broken parts been retrieved from patient¿s mouth? no, the fragment remained in the channel.Has any further medical or surgical treatment been necessary after the event? further treatment is planned.How many times has the instrument been used before the event happened? the instrument was used for the first time.It was new.Additional information received after the information above: the file is still in the mouth/tooth of the patient.If issues arise the tooth will be extracted.This is a follow up for this additional information.Investigation results: proglider 6file sterile 25mm - lot #1890630.Dentsply sirona bensheim reported there was "file breakage".The batch number is known, certificate of conformity is available.No relevant information was found during dhr review (no nonconforming material report was issued during manufacturing or packaging processes).For information, this is the first complaint received involving this batch number for this issue.Please note that this production was made under the following process deviations: si 1012, issued to state an issue which occurs during printings of the labels.A temporary solution was brought by it service.No relation with the subject of the complaint.Si 1031, issued to follow the implementation of a new rinsing machine.No relation with the subject of the complaint.Si 1039, issued to state the use of the new ultrasound machine #6760 still in pending validation.No relation with the subject of the complaint.Si 1042, issued to state the use of the new printing machine zebra zt411 still in pending validation (tests already done showed that printing was conforming).No relation with the subject of the complaint.

• Brand Name: PROGLIDER 6FILE STERILE 25MM
• 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: 22950486
• Report Number: 8031010-2025-00149
• Device Sequence Number: 13159642
• Product Code: EKS
• UDI-Device Identifier: D716PROGLIDE25DEMO1
• UDI-Public: D716PROGLIDE25DEMO1
• 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): 10/15/2025

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: A092622500103
• Device Lot Number: 1890630
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/20/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/20/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 10/08/2025; 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown