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)
Type of Reportable Event	Malfunction
Event or Problem Description
In this event it is reported that automate tool refill 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 has not been returned as of this report.Evaluation results will be submitted as they become available.
Additional Manufacturer Narrative
Returned product was 1 automate iii tightening device and 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 september 2022 (date code 0922) through may 2024 (date code 0524).Complaint is considered substantiated as the returned product meets criteria for capa-2023-519.

• 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: 20025406
• Report Number: 2515379-2024-00041
• Device Sequence Number: 12603609
• Product Code: DZN
• UDI-Device Identifier: D0026631001
• UDI-Public: D0026631001
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2024

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: 663100
• Device Lot Number: 23426213
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/19/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/19/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown