MAUDE Adverse Event Report: SIRONA DENTAL SYSTEMS GMBH MIDWEST LOW SPEED ATTACHMENTS - CONTRA ANGLE SHEATH DENTAL HANDPIECE; HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL

Catalog Number 710074

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

In this event a midwest low speed attachments - contra angle sheath handpiece would not hold burs.No injury resulted in the event.

Manufacturer Narrative

There has been a previous report received with a similar device where this malfunction resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event is reportable per 21cfr part 803.Evaluation of the device found normal chuck wear and the turbine needed to be replaced.The device was repaired and returned to the customer.

Manufacturer Narrative

This report is being submitted individually as a correction to 9614977-2023-00008.Adding additional information for section e : athens dental services inc, - usa adding additional information for date received by manufacturer : 2/2/2023 this is a follow up report for this information.

• Brand Name: MIDWEST LOW SPEED ATTACHMENTS - CONTRA ANGLE SHEATH DENTAL HANDPIECE
• Type of Device: HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, 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: 18240740
• MDR Text Key: 329569617
• Report Number: 9614977-2023-00043
• Device Sequence Number: 1
• Product Code: EGS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K792445
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 710074
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/02/2023
• Patient Sequence Number: 1