MAUDE Adverse Event Report: DENTSPLY PROFESSIONAL MIDWEST TRADITION PLUS COUPLER BACK END WITH FIBER OPTIC; HANDPIECE, AIR-POWERED, DENTAL

Catalog Number 770245

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

As received, the handpiece could support the reported complaint however, a root cause could not be determined.Production and quality testing of the handpiece was not performed as the device was not in working condition.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.Microscopic evaluation revealed some score marks inside the head cavity.Cap cavity and set components appeared to be dry.Poor lubrication practices of the head cavity most likely caused lodging of the cap end bearing inside of the cap which led to set instability which are most likely responsible for the customer complaint.

Event Description

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

• Brand Name: MIDWEST TRADITION PLUS COUPLER BACK END WITH 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: 6194357
• MDR Text Key: 62970906
• Report Number: 1419322-2016-00318
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 12/21/2016

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: 770245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2016
• Initial Date FDA Received: 12/21/2016
• 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: N
• Patient Sequence Number: 1