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

Catalog Number	663100
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
In this event it is reported that a automate tool refill broke during use.No injury occurred.
Additional Manufacturer Narrative
Investigation result: return.5-5-2025: returned product 1 automate iii tightening device with a flexshaft assembly date coded 0924 without original packaging.The flexshaft assembly exhibited evidence of coil deformation/weld failure resulting in the flexshaft assembly to no longer function properly.The retuned automate iii tightening device was inspected and tested using standard testing protocol.The tests included a functional test, which is to use the tool to tighten a matrix band around a tooth model, and a visual inspection for abnormalities.The returned device was observed to have the set screw which controls the torque on the handle to have been tampered/tightened causing the handle to exceed the 8 ¿ 9 ozf-in requirement (as found 18 ozf-in) resulting in flexshafts used for testing to break/fail.By tightening the set-screw after preset during manufacturing, the torque setting will exceed the flexshaft assembly capabilities which will result in the flexshafts breaking.The returned product set screws were relieved to return to 9 ozf-in using a calibrated torque watch and then the functional test was conducted and met specifications and all form/fit/function as per 0290-wi-7.5-42-05 section 5.4 and 0290-ip-7.5-42-05 inspection point #3.The complaint is not substantiated as the customer has tampered with the product resulting in the product non-conformance.This tampering with the automate iii tightening device is the direct root cause for the customers repeat issues with flexshaft assemblies.(nwv).Retain 5-5-2025: retains for item# 20780 batch# 08811097 are not available for review as the product is expensive to manufacture and is not cost efficient to hold a retain for each batch produced.(nwv) dhr 5-5-2025: dhr for item# 663100 lot# 08968397 has been pulled, reviewed, and attached to this case.Dhr review did not indicate any issues during the automate tool refill packaging work order with all inspections completed and deemed acceptable by the operator(s) and quality per 0290-wi-7.5-22-02.Item# 20780 batch# 08811094 is the atuomate iii assy production work order which was utilized to package item# 62422602 lot# 08811097.Dhr for item# 20780 batch# 08811097 has also been pulled, reviewed, and attached to this case.Dhr review did not indicate any issues during assembly of the automate iii tightening device, with all inspections performed by and deemed acceptable by the operator(s) and quality as per 0290-wi-7.5-42-05 & 0290-ip-7.5-42-05.(nwv).

• Brand Name: AUTOMATE TOOL REFILL
• 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: 21559093
• Report Number: 2515379-2025-00002
• Device Sequence Number: 18542196
• Product Code: DZN
• UDI-Device Identifier: D0026631001
• UDI-Public: D0026631001
• 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): 05/06/2025

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: 663100
• Device Lot Number: NOT AVAILABLE
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/07/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/07/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/10/2025
• Supplement Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown