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 a doctor reported that an atc handpiece overheated.There was no injury or 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 reported complaint through testing.The returned handpiece did not meet specifications for speed control or cut performance.Poor lubrication practices were evident in the head cavity which most likely caused lodging of the outer race of the set inside of the cap which led to set instability.This frictional contact most likely led to the heating of the cap area and failure of all cut testing and ball pocket wear/cracking of the cap end bearing retainer.All components looked dry with no sign of lubrication.Root cause code: ct9, cartridge, maintenance/debris.

• 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; susquehanna commerce ctr w.; york, PA 17401 ; 7178457511
• MDR Report Key: 4358188
• MDR Text Key: 5203283
• Report Number: 1419322-2014-00085
• 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: 11/10/2014

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: 11/12/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2014
• Initial Date FDA Received: 12/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2010
• 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