MAUDE Adverse Event Report: DENTSPLY PROFESSIONAL MIDWEST STYLUS PLUS SPK; HANDPIECE, AIR-POWERED, DENTAL

Catalog Number 792430

Device Problems Fitting Problem (2183); Detachment of Device or Device Component (2907)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

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.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.

Event Description

In this event it was reported that the cap unscrewed from a stylus plus handpiece while in use.The reported complaint did not result in an injury or need for intervention.

Manufacturer Narrative

Received the handpiece in pieces, both bearings were off of the turbine shaft, cap was off also.The only visible damage was to the turbine which with both bearings in pieces.The cap was sticking, did not press in and out consistently, evenly.There was no thread damage to either the cap or the inside of the head.I tightened down the cap and it was not cross threaded either.The chuck pusher may have been pressed in and not released.

• Brand Name: MIDWEST STYLUS PLUS SPK
• 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, D-646 25; GM D-64625
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494229
• MDR Report Key: 7518967
• MDR Text Key: 108874558
• Report Number: 1419322-2018-00037
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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,Followup
• Report Date: 07/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 792430
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/28/2018
• 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: Unknown
• Patient Sequence Number: 1