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

Catalog Number 780045

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.As received, the handpiece did support the reported complaint but a root cause could not be determined.There was no evidence of the cap unscrewing under testing conditions where the cap was affixed with the specified torque wrench.The issue of the cap coming off was replicated through testing but only when the cap was unscrewed by a half revolution with pressure set at 30psig.Microscopic evaluation revealed some debris and corrosion within the cap and head cavities and set components.Microscopic evaluation also revealed damage on the rotor blades.Some score marks were also seen within the head cavity.All components looked dry with no evidence of lubrication.

Event Description

In this event it was reported that the 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: 5718568
• MDR Text Key: 47219273
• Report Number: 1419322-2016-00111
• 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: 05/11/2016

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: 780045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/11/2016
• Initial Date FDA Received: 06/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/05/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1