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

Catalog Number 780045

Device Problem Device Operates Differently Than Expected (2913)

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.Production and quality testing of the handpiece was not performed as the device was unable to secure a bur in the chuck and the turbine was cracked.Dentsply was unable to duplicate or determine a cause for the complaint.The head depth dimension (.3705 +-.0005) was oversize by.002 of an inch after debris was removed.Due to lack of lubrication, friction and debris built up in the handpiece over time.The debris at the bottom of the head may have caused the head cavity dimension to be undersize and therefore causing the set to push up against the lever rendering the lever and chuck inoperable.This pressure against the cap may have caused it to loosen and separate from the handpiece.It may also have caused pressure on the bottom of the head causing the bottom dimension to open up by.002 of an inch.Cap, set components, cap end and bur end bearing components all exhibited moderate to severe amounts of debris and/or corrosion.All components were dry and lacked lubrication.

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 L 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: 5455255
• MDR Text Key: 39268937
• Report Number: 1419322-2016-00025
• 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
• Report Date: 01/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 780045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2008
• 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