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

Catalog Number	6602515
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Codes	Burn(s) (1757); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
2 of 3 devices were returned for evaluation.1 device will not be returned for evaluation.Evaluation of two devices found excessive wear due to a lack of proper maintenance.The one device had debris build-up.The devices did not heat up during evaluation.The devices were repaired and returned to the customer.
Event or Problem Description
This report summarizes 3 malfunction events where a midwest e plus 1:5 high speed contra angle attachment handpiece overheated.2 events resulted in no injury.1 event resulted in the patient being slightly burned with no intervention.

• Brand Name: MIDWEST E PLUS 1:5 HIGH SPEED CONTRA ANGLE ATTACHMENT
• Common Device Name: 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: dan eagar ; 221 w. philadelphia st.; york, PA 17401 ; 7178494593
• MDR Report Key: 22564061
• Report Number: 9614977-2025-00019
• Device Sequence Number: 9283142
• Product Code: EFB
• UDI-Device Identifier: E2768752050
• UDI-Public: E2768752050
• Combination Product (Y/N): N
• PMA/510(K) Number: K972436
• Number of Events Summarized: 3
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/21/2025

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?: Yes
• Device Catalogue Number: 6602515
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/22/2025
• Patient Sequence Number: 1
• Patient Sex: Unknown