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.-.

Event Description

In this event it was reported that the cap unscrewed from a tradition plus pb 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 ; 7178457551
• MDR Report Key: 6561970
• MDR Text Key: 75020045
• Report Number: 1419322-2017-00090
• 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: 05/11/2017

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: 04/18/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/11/2017
• Initial Date FDA Received: 05/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2016
• 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