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

Catalog Number 750044

Device Problem Detachment Of Device Component (1104)

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 reported complaint could not be verified via functional testing.The returned handpiece was tested for performance by production operator and failed sound and cut quality, cut time and free speed requirements according to requirements.It was also noted by the production operator that the set is broken and the handpiece is not cutting.Quality testing was not performed due to bur wobbling making the testing impossible.Multiple dimensions on the head and cap were checked by production personnel and all were found to be within specification.The handpiece was then microscopically evaluated by quality personnel.The evaluation revealed significant wear on the rotor and damage to the rotor blades.The bur end bearing was detached from the set assembly and stuck inside the head cavity.This separation of the set pieces was most likely causing the set instability during procedure and causing the cap to unscrew but this could not be confirmed.

Event Description

In this event it was reported that a cap unscrewed from a tradition handpiece while in use.The reported complaint did not result in an injury or need for intervention.

• Brand Name: MIDWEST TRADITION 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: 5683332
• MDR Text Key: 46070796
• Report Number: 1419322-2016-00094
• 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: Dentist
• Type of Report: Initial
• Report Date: 04/26/2016

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: 750044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/26/2016
• Initial Date FDA Received: 05/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2015
• 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