MAUDE Adverse Event Report: DENTSPLY PROFESSIONAL STYLUS ATC; AIR-POWERED DENTAL HANDPIECE

Catalog Number 882300

Device Problem Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

In this event, it was reported that a cap unscrewed from an atc mini handpiece while in use.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.Dentsply was able to verify the complaint for excessive noise but was unable to verify the complaint related to the cap unscrewing.Microscopic retainer.Rubbing marks on the cap end bearing inner race and rotor was also observed as well as dents in the bur tube.The most likely cause of the cap coming unscrewed is instability of the set causing the outer race to become lodged inside the cap.Root cause: cartridge, damaged.

• Brand Name: STYLUS ATC
• Type of Device: AIR-POWERED DENTAL HANDPIECE
• Manufacturer (Section D): DENTSPLY PROFESSIONAL; des plaines IL
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st., ste 60; susquence commerce center w.; york, PA 17401 ; 7178457511
• MDR Report Key: 4359534
• MDR Text Key: 5233291
• Report Number: 1419322-2014-00087
• 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: 11/13/2014

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: 882300
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/19/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/13/2014
• Initial Date FDA Received: 12/12/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1