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
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
Additional serial numbers included in this report: (b)(6).29 of 32 devices were returned for evaluation.We are awaiting the return of 2 devices.1 device will not be returned for evaluation.Evaluation of one device found it to be within specification.Evaluation of four devices found excessive wear due to a lack of proper maintenance.The devices did not heat up during evaluation.The devices were repaired and returned to the customers evaluation of one device found excessive wear due to a lack of proper maintenance and lubrication.The device had debris build-up.This device had a deformation issue (dent).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.A friction problem was identified from pressure on the cap.This device had a deformation issue (dent).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 device did 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 device had debris build-up.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.Evaluation of one device found excessive wear due to a lack of proper maintenance.This device had a deformation issue (dent).The device did not heat up during evaluation.The device was repaired and returned to the customer.Evaluation of four devices found excessive wear due to a lack of proper maintenance.A friction problem was identified from pressure on the cap.The devices did not heat up during evaluation.The devices were repaired and returned to the customers.Evaluation of one device found excessive wear due to a lack of proper maintenance.The device did heat up during evaluation.The device was repaired and returned to the customer.Evaluation of four devices found excessive wear due to a lack of proper maintenance.The devices had debris build-up.The devices did heat up during evaluation.The devices were repaired and returned to the customers.Evaluation of one device found excessive wear due to a lack of proper maintenance.The devices had debris build-up.A friction problem was identified from pressure on the cap.The device did heat up during evaluation.The device was repaired and returned to the customer.Evaluation of three devices found excessive wear due to a lack of proper maintenance.The devices had debris build-up.The devices did not heat up during evaluation.The devices were repaired and returned to the customers.Evaluation of six devices found excessive wear due to a lack of proper maintenance.The devices had debris build-up.A friction problem was identified from pressure on the cap.The devices did not heat up during evaluation.The devices were repaired and returned to the customers.
Event or Problem Description
This report summarizes 31 malfunction events where a midwest e plus 1:5 high speed contra angle attachment handpiece overheated.2 events resulted in the patient being slightly burned with no intervention.29 events that resulted in no injury.

• 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: 19830926
• Report Number: 9614977-2024-00015
• Device Sequence Number: 8046431
• Product Code: EFB
• UDI-Device Identifier: E2768752050
• UDI-Public: E2768752050
• Combination Product (Y/N): N
• PMA/510(K) Number: K972436
• Number of Events Summarized: 31
• 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): 07/23/2024

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: 875205
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/25/2024
• Patient Sequence Number: 1
• Patient Sex: Unknown