MAUDE Adverse Event Report: DENTSPLY LLC AUTOMATRIX SHAFT; INSTRUMENTS, DENTAL HAND

Catalog Number	62422603
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 automatrix shaft broke during use.All the broken parts were retrieved from the patient's mouth.No injury.
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: digital review: product not returned, image in case depicts a view of a flexshaft (date code 1224) with coil deformation/weld failure causing the product to not function properly.Complaint is considered substantiated.Dhr review and retain evaluation will be conducted.Dhr: dhr for item# 62422603 lot# 09736788 has been pulled, reviewed, and attached to this case.Dhr review did not indicate any issues during the execution of the automatrix shaft packaging work order with all inspections completed and deemed acceptable by the operator(s) and quality.Item# 24703 lot# 09605903 is the production work order for the flexshaft in which the customer has complained against (date code 0825).Dhr for item# 24703 batch# 09605903 has also been pulled, reviewed, and attached to this case.Dhr review did not indicate any issues during the assembly work order for the flexible shaft assembly, with all inspections performed and deemed acceptable by the operator(s) and quality as per (b)(4) & (b)(4).Retain: retain for item# 24703 lot# 09605903 has been pulled, inspected per (b)(4) (with exception to destructive testing).The flexshafts were tested by using standard testing protocol.The tests included a functional test, which is to use an automate iii tool and the retain flexshaft to tighten a matrix band (n=5) around a tooth model, and a visual inspection for abnormalities.Retain meets all criteria for form/fit/function of the intended use for the device.

• Brand Name: AUTOMATRIX SHAFT
• 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: 25461450
• Report Number: 2515379-2026-00091
• Device Sequence Number: 16043052
• Product Code: DZN
• UDI-Device Identifier: D010624226051
• UDI-Public: D010624226051
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/10/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: 62422603
• Device Lot Number: 09736788
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/27/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2026
• Initial Report FDA Received Date: 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown