MAUDE Adverse Event Report: SIRONA DENTAL SYSTEMS GMBH MIDWEST STYLUS; HANDPIECE, AIR-POWERED, DENTAL

Catalog Number 792300

Device Problem Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Manufacturer Narrative

Additional serial number included in this report: (b)(4).4 of 4 devices were returned for evaluation.Evaluation of 1 device found chuck wear and lack of maintenance.The device was cleaned of debris and the turbine was replaced.The device was repaired and returned to the customer.Evaluation of 3 devices found normal chuck wear and the turbines needed to be replaced.The devices were repaired and returned to the customers.

Event Description

This report summarizes 4 malfunction events where a midwest stylus handpiece would not hold burs.No injury resulted in any of the events.

Manufacturer Narrative

The information in field d3 was inadvertently missed during the initial submission.This submission is to correct the report to include this additional information.

• Brand Name: MIDWEST STYLUS
• Type of Device: HANDPIECE, AIR-POWERED, DENTAL
• Manufacturer (Section D): SIRONA DENTAL SYSTEMS GMBH; fabrikstrasse 31; bensheim, hessen D-646 25; GM D-64625
• MDR Report Key: 11758364
• MDR Text Key: 251765473
• Report Number: 9614977-2021-00016
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• PMA/PMN Number: K131319
• Number of Events Reported: 4
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 06/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 792300
• Device Lot Number: 3008239M, 3007886B, 3014101M
• Patient Sequence Number: 1