MAUDE Adverse Event Report: DENTSPLY PROFESSIONAL MIDWEST STYLUS LITE 360S (STANDARD); AIR-POWERED DENTAL HANDPIECE

Catalog Number 791300

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

In this event it was reported that the cap on a stylus lite handpiece unscrewed and the turbine fell into a patient's mouth while in use and was easily retrieved.The reported complaint did not result in an injury or need for intervention.

Manufacturer Narrative

Though no medical/surgical intervention was required to preclude a serious injury in this event, there have been previously reported events involving a similar device that resulted in the need for medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function.Therefore, this event meets the criteria for reportability per 21 cfr part 803.As received, the handpiece could not support the reported complaint and a root cause could not be determined.Cut testing with the handpiece could not be performed as the handpiece stalled immediately when bur was introduced into cut test material.The handpiece was then microscopically evaluated.Minor to moderate corrosion was noted inside cap and head cavities as well as on the set components.Some damage to the rotor blades was also observed.The threads and depth of both the cap and the head of the returned handpiece were also measured.All dimensions were found to be within specification.All set components appeared to lack lubrication.

• Brand Name: MIDWEST STYLUS LITE 360S (STANDARD)
• Type of Device: AIR-POWERED DENTAL HANDPIECE
• Manufacturer (Section D): DENTSPLY PROFESSIONAL; des plaines IL
• Manufacturer Contact: helen lewis ; susquehanna commerce ctr w.; 221 w.philadelphia st., ste. 60; york, PA 17401 ; 7178457511
• MDR Report Key: 4568368
• MDR Text Key: 5547328
• Report Number: 1419322-2015-00011
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K003518
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 01/28/2015

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 Operator: Health Professional
• Device Catalogue Number: 791300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/28/2015
• Initial Date FDA Received: 02/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1