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

Device Problem Overheating of Device (1437)

Patient Problems Burn(s) (1757); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Additional serial numbers included in this report: (b)(4).27 of 27 devices were returned for evaluation.Evaluation of 5 devices found them all to be within specification.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.The device had debris build-up.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 for these devices.The devices did not heat up during evaluation.The devices were repaired and returned to the customers.Evaluation of four devices found excessive wear due to a lack of proper maintenance.A friction problem was identified from pressure on the cap for these devices.The devices did 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.A friction problem was identified from pressure on the cap for these devices.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 one device found excessive wear due to a lack of proper maintenance and lubrication.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 four 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 had debris build-up.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.A friction problem was identified from pressure on the cap.This device had a deformation issue (dent).The device 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 27 malfunction events where a midwest e plus 1:5 high speed contra angle attachment overheated.Three patients experienced minor burns, no intervention was required.There was no injury in 23 of the events.There was one event where the patient outcome is unknown.

• Brand Name: MIDWEST E PLUS 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: 15634891
• MDR Text Key: 304716919
• Report Number: 9614977-2022-00062
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• PMA/PMN Number: K972436
• Number of Events Reported: 27
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 875205
• Patient Sequence Number: 1