MAUDE Adverse Event Report: DENTSPLY PROFESSIONAL MIDWEST E PLUS 1:5 HIGHSPEED ATTACHMENT; HANDPIECE, AIR-POWERED, DENTAL

Catalog Number 875205

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 attachment could support the reported complaint however, a root cause could not be determined.Production and quality testing of the attachment was not performed as the device was not in working condition.Attachment was sent to (b)(4) for further evaluation.Results from (b)(4) stated: the attachment was in good condition and well lubricated.The investigation shows that the cap was assembled correctly.The inside of the head cap shows no significant wear or tear.A manufacturing error could not be detected as well.

Event Description

In this event it was reported that the cap came off a midwest e plus 1:5 handpiece while in use.The reported complaint did not result in an injury or need for intervention.

• Brand Name: MIDWEST E PLUS 1:5 HIGHSPEED ATTACHMENT
• Type of Device: HANDPIECE, AIR-POWERED, DENTAL
• Manufacturer (Section D): DENTSPLY PROFESSIONAL; 901 west oakton st.; des plaines IL 60018
• Manufacturer (Section G): SIRONA DENTAL SYSTEMS GMBH; fabrikstrasse 31; bensheim, hessen D-646 25; GM D-64625
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494229
• MDR Report Key: 6424171
• MDR Text Key: 70563643
• Report Number: 1419322-2017-00048
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131319
• 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: 03/22/2017

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: 875205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2017
• Initial Date FDA Received: 03/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2016
• 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