MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL FINGER SPREAD. POINT.25MM10-40; SPREADER, PULP CANAL FILLING MATERIAL, ENDODONTIC

Catalog Number	A020602590000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
In this event it is reported that a finger spread.Point.25mm10-40 broke during use.No injury occurred.
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.Investigation results involved product that broke during use was not returned, and cannot be fully identified and analyzed.Nothing unusual to report was found during dhr review (batch #1754517).Customer stated having repurposed the instrument, which is intended for exclusively manual use, by removing the plastic handle and coupling it with an ultrasonic scaler.Finger spreaders we manufacture are absolutely not intended to be used in this way.This constitutes a misuse from the customer.Root cause is customer misuse.

• Brand Name: FINGER SPREAD. POINT.25MM10-40
• Common Device Name: SPREADER, PULP CANAL FILLING MATERIAL, 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: 24687137
• Report Number: 8031010-2026-00037
• Device Sequence Number: 18573615
• Product Code: EKK
• UDI-Device Identifier: J003A0206025900001
• UDI-Public: J003A0206025900001
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: EXEMPT
• 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
• Report Date (Section B): 03/25/2026

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: A020602590000
• Device Lot Number: 1754517
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/11/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown