MAUDE Adverse Event Report: KAVO DENTAL GMBH SMARTMATIC S20 K DENTAL HANDPIECE

Model Number S20 K

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/17/2021

Event Type  malfunction  

Manufacturer Narrative

An analysis of the product prior to the repair showed normal signs of wear related to the ball bearings, hence it was running out of specification. But the chuck system worked as specified and a bur slippage was not reproducible. Therefore it could only be assumed that either the bur was not inserted and locked correctly or that a bur was used whose shaft did not meet the requested specifications. To avoid such issues the user instruction contains already several notes, warnings and requests how to prepare the handpiece for each treatment and how to use it: 2. 2 technical condition: a damaged device or components could injure patients, users and third parties. Only operate devices or components if they are undamaged on the outside. Check that the device is working properly and is in satisfactory condition before each use have parts with sites of breakage or surface changes checked by the service. If the following defects occur, stop working and have the service personnel carry out repair work: malfunctions. Damage. Irregular running noise. Excessive vibration. Overheating. Tool is not seated firmly in the handpiece. Following expiry of the warranty, have the tool holding system checked once a year. Kavo recommends specifying in-house service intervals where the medical device is brought to a professional shop for cleaning, servicing and a function check. Define the service interval depending on the frequency of use. Note: only use carbide burs or diamond burs that conform to iso 1797-1 type 1, are made of steel or hard metal, and meet the following criteria: shaft diameter: ø 2. 334 to ø 2. 350 mm. Overall length: max. 22 mm. Warning: use of unauthorised dental burs or diamond grinders. Risk of injury. Comply with the instructions for use and use the dental bur or diamond grinder properly. Only use dental burs or diamond grinders that do not deviate from the specified data. Caution: use of dental burs or diamond grinders with worn or damaged shafts. Risk of injury, tool may fall out during treatment. Never use dental burs or diamond grinders with damaged or worn shafts. Caution: hazard from defective chuck system. The tool can fall out and cause injury. Pull on the tool to check if the chucking system is functioning properly and that the tool is firmly clamped. Wear gloves or a thimble when you check, insert, or remove the bits to prevent injury and infection.

Event Description

During a restoration adjustment of a bridge between tooth #17 - 19 the grinder disengaged and fell into patients mouth who swallowed it. Patient declined to go for an x-ray and felt no discomfort. Also during the check-up 4 days later patient declined to have an x-ray as he/she felt no discomfort and was not concerned.

• Brand Name: SMARTMATIC S20 K
• Type of Device: DENTAL HANDPIECE
• Manufacturer (Section D): KAVO DENTAL GMBH; bismarckring 39; biberach / riss, 88400 ; GM 88400
• Manufacturer (Section G): KAVO DENTAL GMBH; bismarckring 39; biberach / riss, 88400 ; GM 88400
• Manufacturer Contact: klaus reisenauer ; bismarckring 39; biberach / riss, 88400 ; GM 88400
• MDR Report Key: 12187908
• MDR Text Key: 262201650
• Report Number: 3003637274-2021-00026
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 07/19/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 07/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: S20 K
• Device Catalogue Number: 1.011.6751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2021
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse