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

Catalog Number 791430

Device Problem Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Manufacturer Narrative

4 of 4 devices were returned for evaluation.Evaluation of 3 devices found normal chuck wear and the turbine needed to be replaced.The device was repaired and returned to the customer.Evaluation of 1 device 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 4 malfunction events where a midwest phoenix handpiece would not hold burs.No injury resulted.

• Brand Name: MIDWEST PHOENIX
• 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.; york, PA 17401 ; 7178494593
• MDR Report Key: 16789735
• MDR Text Key: 313819290
• Report Number: 9614977-2023-00018
• 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: 04/21/2023

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: 791430
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/21/2023
• Patient Sequence Number: 1