MAUDE Adverse Event Report: DENTSPLY LLC AUTOMATRIX INTRO PKG-DUAL; INSTRUMENTS, DENTAL HAND

Catalog Number	663032
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 an automatrix intro pkg-dual broke during use.
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 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
5-19-2025: product not returned; image attached shows 1 automate iii tightening device with 1 flexshaft assembly installed (date code unknown) with weld failure/coil deformation causing the ¿tip¿ to break off.Capa-2023-519 opened to address flexshaft failures for product manufactured by sarasota since september 2022 (date code 0922) through implementation date of may 2024 (date code 0524).Item# 663032 lot# 05834794 utilized item# 20780 lot# 06112038 (atuomate iii assy).Item# 20780 lot# 06112038 utilized item# 24703 lot# 06112006 (flexshaft assembly) which was produced 10-2022.Dhrs attached to case for traceability, complaint is considered substantiated.

• Brand Name: AUTOMATRIX INTRO PKG-DUAL
• Common Device Name: INSTRUMENTS, DENTAL HAND
• Manufacturer (Section D): DENTSPLY LLC; 38 west clarke avenue; milford DE 19963
• Manufacturer (Section G): DENTSPLY LLC; 38 west clarke avenue; milford DE 19963
• Manufacturer Contact: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 21582792
• Report Number: 2515379-2025-00004
• Device Sequence Number: 9456541
• Product Code: DZN
• UDI-Device Identifier: D0026630321
• UDI-Public: D0026630321
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,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: 663032
• Device Lot Number: 05834794
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/06/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/06/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/12/2025
• Supplement Report FDA Received Date: 08/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown