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

Catalog Number 780044

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 the tradition handpiece and the turbine and cap fell into a pt's mouth; both were retrieved.The reported complaint did not result in an injury or need for intervention.

Manufacturer Narrative

Though no med/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 med/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 21 cfr part 803.The investigation could not replicate the reported complaint: the cap remained attached to the head of the handpiece with no sign of walk-off when tightened with the specified wrench.The issue of the cap coming off was only replicated when the cap was deliberately unscrewed by a half revolution with pressure set at 30psig.

• Brand Name: TRADITION L NONFIBER OPTIC HS HANDPIECE
• Type of Device: AIR-POWERED DENTAL HANDPIECE
• Manufacturer (Section D): DENTSPLY PROFESSIONAL; des plaines IL
• Manufacturer Contact: helen lewis ; susquehanna commerce ctr w.; 221 w. philadelphia st. ste 60; york, PA 17401 ; 7178457511
• MDR Report Key: 4273953
• MDR Text Key: 19360229
• Report Number: 1419322-2014-00076
• 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: 10/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 780044
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/23/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2013
• 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