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

Catalog Number 780045

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 cap unscrewed from a tradition handpiece while in use.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 the criteria for reportability per 21 cfr part 803.Microscopic evaluation revealed debris within the head cavities.Dent observed inside the head cavity will cause the roundness dimension to be out of specification.Dentsply is unable to determine how the cap might have come unscrewed as all handpieces are 100% performance tested prior to shipping from dpd.

• Brand Name: TRADITION L FIBER OPTIC HS HANDPIECE
• Type of Device: AIR-POWERED DENTAL HANDPIECE
• Manufacturer (Section D): DENTSPLY PROFESSIONAL; des plaines IL
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st., ste. 60; york, PA 17401 ; 7178457511
• MDR Report Key: 4305205
• MDR Text Key: 5269400
• Report Number: 1419322-2014-00083
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K863677
• 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: 10/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2014
• 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?: Yes
• Date Returned to Manufacturer: 11/04/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2014
• 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: Reuse
• Patient Sequence Number: 1