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

Catalog Number	62422602
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
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 automate iii broke during use.The outcome of this event is unknown as of this mdr.Further information requested.
Additional Manufacturer Narrative
Return: returned product 1 automate iii tightening device and 1 automatrix flexshaft date coded 1023 with weld failure/coil deformation resulting in the ¿tip¿ breaking off.Capa-2023-519 opened to address flexshaft failures for product manufactured by sarasota since september 2022 (date code 0922) through may 2024 (0524).Dhr review and retain evaluation will be conducted.(nwv) dhr review: dhr for item# 62422602 batch# 06786878 has been pulled, reviewed, and attached to this case.Dhr review did not indicate any issues during the execution of the packaging work order for automatrix accessories automate iii, with all inspections completed and deemed acceptable by the operator(s) and quality.Item# 20780 batch# 06435687 is the atuomate iii assy production work order which was utilized to package item# 62422602 batch# 06786878.This production order is to assemble the automate iii tightening device and attach the already assembled flexshaft component only.Item# 24703 batches 06663277 & 06608713 are the production work orders for the flexshaft in which the customer has complained against (date code 0223).Dhrs for item# 24703 batches 06663277 & 06608713 have also been pulled, reviewed, and attached to this case.Dhr reviews did not indicate any issues during the assembly work orders 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.Note that the traceability of the returned product date code stamp does not trace back to any components assembled for item# 62422602 batch# 06786878.(nwv) retain: retains for item# 24703 batches 06663277 & 06608713 have 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).

• 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: 19515199
• Report Number: 2515379-2024-00028
• Device Sequence Number: 17973413
• Product Code: DZN
• UDI-Device Identifier: D010624226011
• UDI-Public: D010624226011
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: 06786878
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/11/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/11/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/11/2024
• 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