MAUDE Adverse Event Report: SIRONA DENTAL SYSTEMS GMBH MIDWEST TRADITION PRO FIBER OPTIC - LEVER - FIXED BACKEND; HANDPIECE, AIR-POWERED, DENTAL

Catalog Number 780345

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

5 of 5 devices were returned for evaluation.Evaluation of 3 devices found normal chuck wear and the turbine needed to be replaced in each device.The devices were repaired and returned to the customers.Evaluation of 2 devices found chuck wear and lack of maintenance.The devices were cleaned of debris and the turbines were replaced.The devices were repaired and returned to the customers.

Event Description

This report summarizes 5 malfunction events.This report summarizes five malfunction events where midwest tradition pro handpieces would not hold dental burs.There were no injuries in any of the events.

• Brand Name: MIDWEST TRADITION PRO FIBER OPTIC - LEVER - FIXED BACKEND
• 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: 9262968
• MDR Text Key: 197368905
• Report Number: 9614977-2019-00137
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• PMA/PMN Number: K131319
• Number of Events Reported: 5
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 780345
• Type of Device Usage: N
• Patient Sequence Number: 1