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

Catalog Number 882300

Device Problem Overheating of Device (1437)

Patient Problem Burn, Thermal (2530)

Event Type  malfunction  

Event Description

In this event a doctor reported that an atc handpiece overheated and burned a patient.The patient was administered an ointment with a numbing agent.

Manufacturer Narrative

Though no medical/surgical intervention was required to preclude a serious injury in this event, there have been previously reported events involving this 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.The returned handpiece was tested and did not meet production specifications for speed control and cut performance.It was also noted by manufacturing personnel that the cap is heating up.Quality personnel then investigated the handpiece.The handpiece exhibited maximum temperature of 58.5 degrees celsius during free run testing and 59.7 degrees celsius during load testing.Poor lubrication practices of the head cavity 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, 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 present.

• Brand Name: STYLUS ATC
• Type of Device: AIR-POWERED DENTAL HANDPIECE
• Manufacturer (Section D): DENTSPLY PROFESSIONAL; des plaines IL
• Manufacturer Contact: helen lewis ; susquehanna commerce center w.; 221 w. philadelphia st. ste. 60; york, PA 17401 ; 7178457511
• MDR Report Key: 4380632
• MDR Text Key: 5240058
• Report Number: 1419322-2014-00090
• 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: 12/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2014
• 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: 12/05/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2012
• 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