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

Catalog Number 790044

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 could support the reported complaint.However, a root cause could not be determined.Cut testing with the handpiece could not be performed as the handpiece stalled immediately when bur was introduced into cut test material.The handpiece was then microscopically evaluated by quality personnel.Significant debris was noted inside cap and head cavities.Some rubbing marks were seen within the head cavity.Some damage to the rotor blades was also observed.Microscopic evaluation also revealed significant wear on the rotor.The threads and depth of both the cap and the head of the returned handpiece were measured by manufacturing personnel.All dimensions were found to be within specification.The combination of debris, friction between parts, and instability of the set due to a cap end bearing failure are most likely responsible for the complaint.In addition, all components looked dry and corroded with no sign 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 PB NON 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: 5428796
• MDR Text Key: 37977544
• Report Number: 1419322-2016-00015
• 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: 01/11/2016

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: 790044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2016
• Initial Date FDA Received: 02/10/2016
• 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