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

Catalog Number 62422603

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 02/08/2024

Event Type  malfunction  

Event Description

In this event it is reported that automatrix shaft broke during use.The outcome of this event is unknown as of this mdr.

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 results are not available as of this report.Evaluation results will be submitted as they become available.

Manufacturer Narrative

Returned product was 1 flexshaft date code 0223 with coil deformation/weld failure causing the product to not function properly.Capa-2023 opened to address automatrix flexshaft assemblies breaking for product manufactured by sarasota since september 2022 (date code 0922) through present.Complaint is considered substantiated.There is no batch information provided in case and therefore dhr review and retain evaluation cannot be conducted.(nwv).

• Brand Name: AUTOMATRIX SHAFT
• 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: 18768209
• MDR Text Key: 336981406
• Report Number: 2515379-2024-00012
• Device Sequence Number: 1
• Product Code: DZN
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 62422603
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/21/2024
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1