MAUDE Adverse Event Report: NOUVAG AG MD11, 40'000RPM MOTOR WITH 20:1 CONTRA ANGLE

Model Number 2027

Device Problem Sticking (1597)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/25/2017

Event Type  malfunction  

Event Description

Per complaint# (b)(4) , complainant reports a device malfunction for vendor part, nouvag implant machine md11, in which the drill got stuck in the handpiece.There was no patient impact reported.F the device was defective to cause the event described in the complaint, in worse case scenario, if the clinician did not have any other handpiece he would have to stop surgery and do another procedure later.

• Brand Name: MD11, 40'000RPM MOTOR WITH 20:1 CONTRA ANGLE
• Type of Device: MD11
• Manufacturer (Section D): NOUVAG AG; st gallerstrasse 23-25; goldach, CH-94 03; SZ CH-9403
• MDR Report Key: 7427431
• MDR Text Key: 105539803
• Report Number: 3001617766-2018-00058
• Device Sequence Number: 1
• Product Code: DZI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 03/12/2018,04/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Model Number: 2027
• Device Catalogue Number: 2027
• Device Lot Number: 1169E1704R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/26/2017
• Event Location: Other
• Date Report to Manufacturer: 03/12/2018
• Type of Device Usage: N
• Patient Sequence Number: 1