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

Catalog Number 790045

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

In this event it was reported that a cap unscrewed from a tradition handpiece and the turbine came out during the procedure.The reported complaint did not result in an injury or need for intervention.

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 criteria for reportability per 21 cfr part 803.As received, the handpiece could not support the reported complaint and 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 cap only moved when it was unscrewed by half a revolution during testing.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 significant debris within the cap and head cavities and set components.Some rubbing marks were also seen within the head cavity.All components looked dry with no evidence of lubricant.Dentsply is unable to determine how the cap might have come unscrewed as all handpieces are 100% performance tested prior to shipping.

• Brand Name: MIDWEST TRADITION PB FIBER OPTIC
• Type of Device: AIR-POWERED DENTAL HANDPIECE
• Manufacturer (Section D): DENTSPLY PROFESSIONAL; des plaines IL
• Manufacturer Contact: helen lewis ; susquehanna commerce center w.; 221 w. philadelphia st. ste 60; york, PA 17401 ; 7178457511
• MDR Report Key: 4517335
• MDR Text Key: 17297135
• Report Number: 1419322-2015-00003
• 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: 01/12/2015

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: 790045
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/13/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2015
• Initial Date FDA Received: 02/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2010
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1