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

Catalog Number 875101

Device Problem Overheating of Device (1437)

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

Event Type  malfunction  

Manufacturer Narrative

Additional serial numbers included in this report: (b)(4).2 of 18 devices were returned for evaluation.We are awaiting the return of 16 devices.Evaluation of one device found excessive wear due to a lack of proper maintenance.The devices had debris build-up.The device did not heat up during evaluation.The device was repaired and returned to the customer.Evaluation of one device found excessive wear due to a lack of proper maintenance and lubrication.The devices had debris build-up.The device did not heat up during evaluation.The device was repaired and returned to the customer.

Event Description

This report summarizes 18 malfunction events where a midwest e mini handpiece overheated.No injury resulted in any of the events.

• Brand Name: MIDWEST E MINI 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
• 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: 12257011
• MDR Text Key: 264494578
• Report Number: 9614977-2021-00032
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• PMA/PMN Number: K972436
• Number of Events Reported: 18
• 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: 07/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 875101
• Type of Device Usage: N
• Patient Sequence Number: 1