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

Manufacturer Narrative

2 of 2 devices were returned for evaluation.Evaluation of 2 devices found normal chuck wear and the turbine needed to be replaced.The device was repaired and returned to the customer.

Event Description

This report summarizes 2 malfunction events where midwest low speed attachments - contra angle sheath would not hold burs.No injury resulted.

Manufacturer Narrative

This is a follow up report to correct information that was reported in the initial report.Correcting product code from egs to efb.Correcting 510k number from k792445 to k192409.

Manufacturer Narrative

Events are not eligible for summary report.These will be submitted individually.

Manufacturer Narrative

Events were submitted under individual report numbers 9614977-2023-00043 and 9614977-2023-00044.This is a follow up report for this additional information.

• Brand Name: MIDWEST LOW SPEED ATTACHMENTS - CONTRA ANGLE SHEATH
• 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.; york, PA 17401 ; 7178494593
• MDR Report Key: 16781288
• MDR Text Key: 313693361
• Report Number: 9614977-2023-00008
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• PMA/PMN Number: K192409
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Catalogue Number: 710074
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1