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 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 shaft broke during use.Fragment recovered.No injury.
Additional Manufacturer Narrative
On 2-15-2024: returned product was 1 flexshaft assembly date coded 1222 with coil deformation/weld failure causing the ¿tip¿ to break off resulting in the product to not function properly.Capa opened to address automatrix flexshaft assemblies breaking for product manufactured by sarasota since september 2022 (date code 0922) through present.Complaint is considered substantiated as the returned product meets criteria for capa.Dhr and retain evaluation will not be conducted however as the traceability for item# 62422603 batch# 07044737 traces to flexshaft assembly production work order for item# 24703 batch# 06924308 which was produced in 05-2023 therefore the date code would be 0523 which does not align with the returned product (dhrs attached for traceability).(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: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 18526361
• Report Number: 2515379-2024-00004
• Device Sequence Number: 20765215
• Product Code: DZN
• UDI-Device Identifier: D0026630161
• UDI-Public: D0026630161
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 02/21/2024

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: 7044737
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/16/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/16/2024
• Supplement Date Received by Manufacturer: 01/16/2024
• Initial Report FDA Received Date: 01/17/2024
• Supplement Report FDA Received Date: 02/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown