MAUDE Adverse Event Report: DENTSPLY PROFESSIONAL ESTYLUS 1:5 HIGH SPEED CONTRA ANGLE ATTACHMENT; HANDPIECE, AIR-POWERED, DENTAL

Catalog Number 774105

Device Problem Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Production personnel tested attachment as per test requirements and found the attachment passed all test requirements.Quality personnel tested attachment and found it met (b)(4) and specification for operating temperature in all test modes.The attachment then was disassembled and microscopically inspected to find a possible cause for the rise in temperature.The internal components of the head and main drive assembly exhibited a slight to moderate amount of debris and/or corrosion on the internal parts.Slight to moderate wear was also noted on internal components.There was a general lack of lubrication inside the head component and main drive area.The bur end bearing components were unable to be retrieved because the bur end bearing outer race was seized into the head cavity.The bur end bearing inner race and retainer were destroyed and probably accounted for the debris noted during disassembly.Although the attachment was in operational condition, the inner components indicate that a lack of maintenance may have caused an accelerated wear of the internal components.This, in turn could have caused the breakdown of the bur end bearing components causing the debris and/or corrosion found in the internal components.This combination of events could have caused an increase in friction and therefore, the increase in temperature reported.

Event Description

In this event a doctor reported that an estylus 1:5 attachment overheated.There was no injury or intervention.

• Brand Name: ESTYLUS 1:5 HIGH SPEED CONTRA ANGLE ATTACHMENT
• Type of Device: HANDPIECE, AIR-POWERED, DENTAL
• Manufacturer (Section D): DENTSPLY PROFESSIONAL; 901 west oakton st.; des plaines IL 60018
• Manufacturer (Section G): DENTSPLY PROFESSIONAL; 901 west oakton st.; des plaines IL 60018
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494229
• MDR Report Key: 6215635
• MDR Text Key: 63639563
• Report Number: 1419322-2016-00321
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031145
• 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: 12/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 774105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2016
• 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