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

Catalog Number 791300

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

2 of 2 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 1 device found a cartridge from another manufacturer, which is not compatible with our device.The device was repaired and returned to the customer.

Event Description

This report summarizes 2 malfunction events.This report summarizes two malfunction events where a midwest stylus handpiece won't hold burs.There were no injuries in any of the events.

• Brand Name: MIDWEST STYLUS HANDPIECE
• Type of Device: HANDPIECE, AIR-POWERED, DENTAL
• Manufacturer (Section D): SIRONA DENTAL SYSTEMS GMBH; fabrikstrasse 31; bensheim, D-646 25; GM D-64625
• Manufacturer (Section G): SIRONA DENTAL SYSTEMS GMBH; fabrikstrasse 31; bensheim, D-646 25; GM D-64625
• Manufacturer Contact: karl nittinger ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494424
• MDR Report Key: 9639607
• MDR Text Key: 184710995
• Report Number: 9614977-2019-00180
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• PMA/PMN Number: K003518
• Number of Events Reported: 2
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 01/28/2020

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 Operator: No Information
• Device Catalogue Number: 791300
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/28/2020
• Type of Device Usage: N
• Patient Sequence Number: 1