MAUDE Adverse Event Report: KAVO DENTAL GMBH SMARTTORQUE MINI LUX S615 L; DENTAL HANDPIECE

Model Number S615 L

Device Problems Retraction Problem (1536); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/04/2022

Event Type  malfunction  

Event Description

During final shaping of a composite restoration on tooth #13 the used bur got lost.As the patient had no respiratory symptoms and it was not located in the suction trap, it was suspected that the patient swallowed it.Therefore; patient was sent to er for x-rays.Doctor of er called dentist's office to confirm that nothing was found in the chest or abdominal x-ray.Bur was not swallowed or aspirated.

Manufacturer Narrative

During the visual and functional inspection prior to the repair it was already noticeable that the retention force of the chuck system was too low and hence the burs have not been held correctly.It was also found that the ball bearings have been running gritty and stiff.After disassembly of the product it got visible that the ball bearings have been worn out.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.Caution: defective clamping system.Risk of injury, dental bur may fall out during treatment.Pull on the dental bur to check if the clamping system works properly and if the dental bur is firmly clamped.

• Brand Name: SMARTTORQUE MINI LUX S615 L
• 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: 14110594
• MDR Text Key: 298813467
• Report Number: 3003637274-2022-00020
• 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: 04/14/2022

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 Model Number: S615 L
• Device Catalogue Number: 1.008.1643
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/17/2022
• Initial Date FDA Received: 04/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1