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
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.
Event or Problem Description
In this event it is reported that a automatrix shaft broke during use.No injury.
Additional Manufacturer Narrative
Investigation results: return 2-4-2025: returned product 1 flexshaft date coded 0624 with coil deformation/weld failure causing the product to not function properly.Complaint is considered substantiated.Dhr review and retain evaluation will be conducted.(nwv).Retain 2-4-2025: retain for item# 24703 lot# 08678369 has been pulled, inspected per 0290-wi-7.5-42-04 (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.(nwv).Dhr 2-4-2025: dhr for item# 62422603 lot# 08837689 has been pulled, reviewed, and attached to this case.Dhr review did not indicate any issues during the execution of the packaging work order with all inspections completed and deemed acceptable by the operator(s) and quality.Item# 24703 lot# 08678369 is the production work order for the flexshaft in which the customer has complained against (date code 0624).Dhr for item# 24703 batch# 08678369 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 0290-wi-7.5-42-04 & 0290-ip-7.5-42-06.Per the wi, weld testing for the 1st 10 subassemblies of every order and every 25th subassembly is conducted and documented.Assemblies are then to bake at 180*f for 30 minutes minimum and documented.Functional test for set screw crimping conducted on the 1st assembly and every 50th assembly in the order and documented.12 in-ounce torque test is performed on 100% of the flexshafts and documented.Torque to fail test is performed every 125th flexshaft assembly and the final assembly in the order for minimum requirement of 1.25 inch-pounds and documented.(nwv).

• 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: 21034832
• Report Number: 2515379-2024-00057
• Device Sequence Number: 13050430
• Product Code: DZN
• UDI-Device Identifier: D010624226011
• UDI-Public: D010624226011
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 02/07/2025

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: 62422603
• Device Lot Number: 08837689
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/23/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/23/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown