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
While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury.Therefore, this event meets the criteria for reportability per 21 cfr 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.
Event or Problem Description
In this event it is reported that automatrix shaft broke during use.No injury.
Additional Manufacturer Narrative
Returned product was 1 flexshaft date code 0621 with coil deformation/weld failure causing the product to not function properly.Capa-2021-375 opened to address weld failures for product manufactured by sarasota since december 2020 (date code 1220) through implementation date of august 2022 (0822).Note the flexshaft was produced in 06-2021 and exceeds the automate flexshaft useful life rationale which states that automate flexshaft useful life will be established as 24 months, and that if meeting these criteria, complaints will be closed as a repair because the device is beyond its useful life (rationale attached).Dhr review cannot be conducted as there is no batch information provided in case.(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: 19329686
• Report Number: 2515379-2024-00025
• Device Sequence Number: 6816179
• Product Code: DZN
• UDI-Device Identifier: D010624226011
• UDI-Public: D010624226011
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 06/18/2024

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: 62422603
• Device Lot Number: 08063937
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/13/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/16/2024
• Supplement Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown