MAUDE Adverse Event Report: DENTSPLY LLC AUTOMATRIX EXTRA SHAFT ASSY; INSTRUMENTS, DENTAL HAND

Model Number	663016
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 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 automatrix extra shaft assy broke in patient's mouth during use.No injury occurred.
Additional Manufacturer Narrative
6-29-2023: product not returned, however image attached depicts an automate iii handle assembly with flexshaft installed (date code could not be verified with image) with coil deformation caused by weld failure rendering the product unusable.Capa-2021-375 opened to address weld failures, coil/spring tears/deformation and ¿broken tip¿ for product manufactured by sarasota since december 2020 (date code 1220) through implementation date of (b)(6) 2022 (0822).Batch 04961585 of item# (b)(4) utilized flexshaft assembly item (b)(4) batch 04908247 which was produced in october 2021 (date code 1021).(nwv) 7-3-2023: see attachment word document for dhr review and retain evaluation (limited to 1000 characters only in this text field).(nwv).

• Brand Name: AUTOMATRIX EXTRA SHAFT ASSY
• 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: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 16853982
• Report Number: 2515379-2023-00073
• Device Sequence Number: 6526841
• Product Code: DZN
• UDI-Device Identifier: D0026630161
• UDI-Public: D0026630161
• 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): 07/11/2023

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 Model Number: 663016
• Device Catalogue Number: 663016
• Device Lot Number: 04961585
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/02/2023
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/02/2023
• Supplement Date Received by Manufacturer: 05/02/2023
• Initial Report FDA Received Date: 05/02/2023
• Supplement Report FDA Received Date: 07/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown