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

Catalog Number 791400

Device Problem Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Manufacturer Narrative

2 of 2 devices were returned for evaluation.Evaluation of 1 device 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 device was cleaned of debris and the turbine was replaced.The device was repaired and returned to the customers.

Event Description

This report summarizes 2 malfunction events where a midwest phoenix handpiece would not hold burs.No injury resulted in any of the events.

• 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.; suite 60w; york, PA 17401 ; 7178494593
• MDR Report Key: 12257084
• MDR Text Key: 264486122
• Report Number: 9614977-2021-00042
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• PMA/PMN Number: K131319
• Number of Events Reported: 2
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 07/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 791400
• Type of Device Usage: N
• Patient Sequence Number: 1