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

Catalog Number	792400
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
2 of 2 devices were returned for evaluation.Evaluation of one device found excessive wear due to a lack of proper maintenance.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.A friction problem was identified from pressure on the cap.The device did not heat up during evaluation.The device was repaired and returned to the customer.The two events reported is for the same device that was evaluated and repaired and then returned again.It was evaluated and repaired for the same issue and returned to the customer.
Event or Problem Description
This report summarizes 2 malfunction events where a midwest stylus® plus spm handpiece overheated.2 events resulted in no injury.

• Brand Name: MIDWEST STYLUS® PLUS SPM
• 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: 21232203
• Report Number: 9614977-2024-00034
• Device Sequence Number: 14524880
• Product Code: EFB
• UDI-Device Identifier: E2767924000
• UDI-Public: E2767924000
• Combination Product (Y/N): N
• PMA/510(K) Number: K131319
• Number of Events Summarized: 2
• 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): 01/18/2025

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: 792400
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/24/2025
• Patient Sequence Number: 1
• Patient Sex: Unknown