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

Catalog Number 780044

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

In this event it is reported that a cap unscrewed from a tradition hand piece 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 has been a previously reported event involving 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 could support the reported complaint for "the turbine back-cap unscrewed and fel into the pt's mouth"; however, a root cause could not be determined.Production and quality testing of the handpiece was not performed as the device was not in working condition.Multiple dimensions on the head and cap were checked by production personnel.The handpiece was then microscopically evaluated by quality personnel.The evaluation revealed damage to the rotor blades.It also revealed significant debris build up within the cap and head cavities.The handpiece head was found dented.The head cavity exhibited some damage/deformation.Damage to the bearing could have increased vibration within the head cavity, causing the cap to unscrew but this could not be confirmed.

• Brand Name: TRADITION L NONFIBER OPTIC HS HANDPIECE
• Type of Device: HANDPIECE, AIR-POWERED, DENTAL
• 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: 4230560
• MDR Text Key: 4970661
• Report Number: 1419322-2014-00062
• 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: 09/11/2014

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: 780044
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/11/2014
• Initial Date FDA Received: 10/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2012
• 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