MAUDE Adverse Event Report: DENTSPLY PROFESSIONAL MIDWEST TRADITION PB NON FIBER OPTIC; HANDPIECE, AIR-POWERED, DENTAL

Catalog Number 790044

Device Problem Overheating of Device (1437)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

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 did not meet back pressure and cut specifications criteria.Quality personnel then investigated the handpiece.The handpiece exhibited maximum temperature of 22.1 c during free run testing and 20.5 c during load testing.Per iso 13732-1, these temperature levels do not reach the burn threshold regardless of the contact period.Microscopic evaluation revealed debris within the cap cavity and set assembly.Microscopic evaluation revealed significant wear on the inside surface of the cap button that faces the pusher and on the pusher itself.This indicates severe interaction between these two mechanisms at high rotational speeds which most likely creates heat noted in the complaint.

Event Description

In this event a doctor reported that a tradition handpiece overheated.The event outcome is unknown as of this mdr evaluation.Additional information is being requested.

Manufacturer Narrative

Additional information received that there was no injury to the patient or clinician.

• Brand Name: MIDWEST TRADITION PB NON FIBER OPTIC
• 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: 5192225
• MDR Text Key: 29983803
• Report Number: 1419322-2015-00114
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K963050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Catalogue Number: 790044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/03/2013
• 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