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

Catalog Number	875105
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).25 of 25 devices were returned for evaluation.Evaluation of two devices found them all to be within specification.Evaluation of two 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 customer.Evaluation of two devices found excessive wear due to a lack of proper maintenance and lubrication.The devices did not heat up during evaluation.The devices were repaired and returned to the customer.Evaluation of two devices found excessive wear due to a lack of proper maintenance and lubrication.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 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 five 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 customer.Evaluation of four 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 customer.Evaluation of seven 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 customer.
Event or Problem Description
This report summarizes 25 malfunction events where a midwest e pro 1:5 high speed contra angle attachment handpiece overheated.18 events resulted in no injury.5 events resulted in the patient being slightly burned with no intervention.1 event resulted in the patient being burned but the outcome is unknown.1 event resulted in the patient being slightly burned with rx prescribed.

• Brand Name: MIDWEST E PRO 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: hannah seevaratnam ; 221 w. philadelphia st.; york, PA 17401 ; 7178494593
• MDR Report Key: 18556627
• Report Number: 9614977-2023-00048
• Device Sequence Number: 12661776
• Product Code: EFB
• UDI-Device Identifier: E2768751050
• UDI-Public: E2768751050
• Combination Product (Y/N): N
• PMA/510(K) Number: K972436
• Number of Events Summarized: 25
• 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): 01/16/2024

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: 875105
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/22/2024
• Patient Sequence Number: 1
• Patient Sex: Unknown