MAUDE Adverse Event Report: DENTSPLY LLC AUTOMATE III; INSTRUMENTS, DENTAL HAND

Catalog Number	62422602
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 automate iii broke during use.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.The device is available for evaluation, though results are not available as of this report.Evaluation results will be submitted as they become available.
Additional Manufacturer Narrative
Return: (b)(6) 2024: returned product was 1 flexshaft assembly date coded 0224 with coil deformation/weld failure causing the product to not function properly.Capa-2023-519 opened to address automatrix flexshaft assemblies breaking for product manufactured by sarasota since (b)(6) 2022 (date code 0922) through (b)(6) 2024 (date code 0524).Complaint is considered substantiated as the returned product meets criteria for capa-2023-519.Dhr and retain evaluation will be conducted however as the traceability for item# 62422603 batch# 08586671 traces to flexshaft assembly production work order for item# 24703 batch# 08390224 which was produced in (b)(6) 2024 therefore the date code would be 0424 which does not align with the returned product (dhrs attached for traceability).((b)(6)) dhr review: (b)(6)2024: dhr for item# 62422603 batch# 08586671 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# 62422603 batch# 08586671 utilized item# 24703 batch# 08390224 flexshaft assembly in which the customer has complained against.Dhr for item# 24703 batch# 08390224 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 ever 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.((b)(6)) retain evaluation: (b)(6)2024: retain for item# 20780 batch# 08390224 (item/batch of the flexshaft assembly utilized to package item# 62422603 batch# 08586671) has been pulled, inspected per 0290-wi-7.5-42-04 (with exception to destructive testing).The flexshaft was 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 met all criteria for form/fit/function of the intended use for the device.((b)(6)).

• Brand Name: AUTOMATE III
• 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: 19589159
• Report Number: 2515379-2024-00029
• Device Sequence Number: 3505610
• Product Code: DZN
• UDI-Device Identifier: D010624226011
• UDI-Public: D010624226011
• 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
• Report Date (Section B): 07/11/2024

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: 62422602
• Device Lot Number: 08586671
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/20/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/20/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 07/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown