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

Catalog Number 882300

Device Problem Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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.The returned handpiece was tested by manufacturing personnel and failed for cut time and speed control tests according to specification.Quality personnel then investigated the handpiece.The handpiece exhibited maximum temperature of 30.1°c during free run testing.Per iso 13732-1, this temperature level does not qualify as a burn regardless of the contact period.Because the handpiece bur stalled as it was introduced into the test material, cut testing was unable to be conducted.Poor lubrication of the head cavity most likely caused lodging of the set assembly inside of the cap which led to set instability.Debris and corrosion were noted on several internal components.Most likely, this was due to a lack of lubrication.It is possible that a lack of lubrication could cause an increase in friction of the internal parts.This increase in friction could then cause an accelerated wear of the internal components resulting in the debris noted above.This increase in friction and debris buildup could have caused the overheating, burning odors and debris emitting from the pushbutton cap assembly as noted in the original complaint.

Event Description

In this event a doctor reported that an atc mini overheated.There was no injury or intervention.

• Brand Name: MIDWEST STYLUS ATC HANDPIECE
• 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: 5971633
• MDR Text Key: 55436941
• Report Number: 1419322-2016-00245
• 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: 08/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2016
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2011
• 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