MAUDE Adverse Event Report: SIRONA DENTAL SYSTEMS GMBH MIDWEST E PLUS 1:5 HIGH SPEED CONTRA ANGLE ATTACHMENT; HANDPIECE, AIR-POWERED, DENTAL

Catalog Number 875205

Device Problem Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Manufacturer Narrative

Additional serial numbers included in this report: (b)(4).10 of 10 devices were returned for evaluation.Evaluation of 10 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.

Event Description

This report summarizes 10 malfunction event where a midwest e plus handpiece would not hold burs.No injury resulted.

Manufacturer Narrative

The information in field d3 was inadvertently missed during the initial submission.This submission is to correct the report to include this additional information.

• Brand Name: MIDWEST E PLUS 1:5 HIGH SPEED CONTRA ANGLE ATTACHMENT
• Type of Device: HANDPIECE, AIR-POWERED, DENTAL
• Manufacturer (Section D): SIRONA DENTAL SYSTEMS GMBH; fabrikstrasse 31; bensheim, hessen D-646 25; GM D-64625
• MDR Report Key: 11758374
• MDR Text Key: 251767788
• Report Number: 9614977-2021-00025
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• PMA/PMN Number: K972436
• Number of Events Reported: 10
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 06/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 875205
• Device Lot Number: 200850, 2413, 200218, 200850
• Patient Sequence Number: 1