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

Catalog Number 62422602

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

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 Description

In this event it is reported that automate iii broke during use.No injury.

Manufacturer Narrative

Returned product was 1 automate iii tightening device and 1 flexshaft assembly date coded 0623 with coil deformation/weld failure causing the "tip/burr component to break off resulting in the product to not function properly.Capa-2023 opened to address automatrix flexshaft assemblies breaking for product manufactured by sarasota since (b)(6) 2022 (date code 0922) through present.There is no batch information provided in case and therefore dhr review and retain evaluation cannot be conducted.Complaint is considered substantiated.(nwv).

• Brand Name: AUTOMATE III
• Type of Device: 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: 18636080
• MDR Text Key: 334541019
• Report Number: 2515379-2024-00009
• Device Sequence Number: 1
• Product Code: DZN
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 62422602
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/01/2024
• Date Manufacturer Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1