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

Catalog Number 792430

Device Problem Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Event Description

This report summarizes 31 malfunction events where a midwest stylus plus handpiece would not hold burs.No injury resulted.

Manufacturer Narrative

Additional serial numbers included in this report: (b)(4).27 of 31 devices were returned for evaluation.We are awaiting the return of 4 devices.Evaluation of 16 devices found normal chuck wear and the turbine needed to be replaced.The device was repaired and returned to the customer.Evaluation of 11 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.

• Brand Name: MIDWEST STYLUS PLUS
• 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: 16789755
• MDR Text Key: 313764823
• Report Number: 9614977-2023-00023
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• PMA/PMN Number: K131319
• Number of Events Reported: 31
• 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

• Date FDA Received: 04/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Catalogue Number: 792430
• Patient Sequence Number: 1