MAUDE Adverse Event Report: DENTSPLY PROFESSIONAL MIDWEST TRADITION PLUS FIXED BACK END; HANDPIECE, AIR-POWERED, DENTAL

Catalog Number 770044

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.Production testing of the handpiece was not performed as the device was not in working condition as received.Quality personnel then investigate the handpiece.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 minor debris within the cap and head cavities.Microscopic evaluation also revealed slight damage on the rotor blades.Instability of the set due to a cap end bearing retainer failure could have created additional vibrations in and about the head, encouraging the cap to come off during use.However, this theory could not be proven as the set was inoperable as received.All components looked dry and slightly corroded.

Event Description

In this event it was reported that a 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 PLUS FIXED BACK END
• 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: 5504937
• MDR Text Key: 40528544
• Report Number: 1419322-2016-00035
• 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: 02/16/2016

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: 770044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2016
• Initial Date FDA Received: 03/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1