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

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 4 devices were returned for evaluation.We are awaiting the return of 1 device.Evaluation of 3 devices found normal chuck wear and the turbine needed to be replaced.The device was repaired and returned to the customer.

Event Description

This report summarizes 4 malfunction events where a midwest tradition pro handpiece would not hold burs.No injury resulted.

• Brand Name: MIDWEST TRADITION PRO HANDPIECE
• Type of Device: HANDPIECE, AIR-POWERED, DENTAL PRODUCT CODE EFB
• 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.; york, PA 17401 ; 7178494593
• MDR Report Key: 16781292
• MDR Text Key: 313818942
• Report Number: 9614977-2023-00011
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/20/2023

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?: No
• Device Catalogue Number: 780345
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/20/2023
• Patient Sequence Number: 1