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

Catalog Number 780345

Device Problem Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Manufacturer Narrative

3 of 3 devices were returned for evaluation.Evaluation of 2 devices found normal chuck wear and the turbines needed to be replaced.The devices were repaired and returned to the customers.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.

Event Description

This report summarizes 3 malfunction events where a midwest tradition pro handpiece would not hold burs.No injury resulted in any of the events.

• Brand Name: MIDWEST TRADITION PRO HANDPIECE
• Type of Device: HANDPIECE, AIR-POWERED, DENTAL
• Manufacturer (Section D): SIRONA DENTAL SYSTEMS GMBH; fabrikstrasse 31; bensheim, hessen D-646 25; GM D-64625
• Manufacturer (Section G): SIRONA DENTAL SYSTEMS GMBH; fabrikstrasse 31; bensheim, hessen D-646 25; GM D-64625
• Manufacturer Contact: hannah seevaratnam ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494593
• MDR Report Key: 14251669
• MDR Text Key: 290452439
• Report Number: 9614977-2022-00018
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• PMA/PMN Number: K131319
• Number of Events Reported: 3
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 780345
• Patient Sequence Number: 1