MAUDE Adverse Event Report: KAVO DENTAL GMBH SMARTTORQUE LUX S619 L; DENTAL HANDPIECE

Model Number S619 L

Device Problems Misassembly by Users (3133); Device Handling Problem (3265)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/14/2016

Event Type  malfunction  

Manufacturer Narrative

The analysis showed that the product was running within the valid specification, but the retention force of the chucking system was too low.A closer look to the chucking system showed that it had grinding marks on the surface which has contact to the entered bur.This indicates that the bur was jammed while the chuck was spinning.This again causes a very high wear and causes in the end that the retention force is reduced quickly.To ensure that the strong wear is not a material issue of the chuck the hardness was tested.It was also found within specification.The most likely explanation is therefore that the tool (bur) which was used does not meet the specification which are given in the user instruction.If the shaft diameter of the tool is slightly too low or the clamping length is too low it is hold in the chuck but has a lower retention force.If it gets used anyhow it gets jammed due to the resistance of the tooth but the handpiece is still turning.This causes exactly what is described above.We have been asking several times for a sample of the used tools to verify the suspicion but we did not get any answer regarding this request.To avoid such issues the user instruction contains several notes, warnings and requests which inform about the requested tool characteristics and the correct preparation for a treatment: warning: hazards for the care provider and the patient.In the case of damage, irregular running noise, excessive vibration, untypical warming or when the cutter or grinder cannot be held.-> do not use further and notify service.Chapter 5.3 insert the milling cutter or diamond grinder.Note: only use carbide cutters or diamond grinders that comply with iso 1797-1 type 3, are made of steel or hard metal and meet the following criteria: - shaft diameter: 1.59 to 1.60 mm.- overall length smarttorque lux s619 l and smarttorque s619 c: max.25 mm.- shaft clamping length smarttorque lux s619 l: at least 11 mm.- blade diameter: max.2 mm.Warning: use of unauthorised cutters or grinders.Injury to the patient or damage to the medical device.-> observe the instructions for use and use the cutter or grinder properly.-> only use cutters or grinders that do not deviate from the specified data.Caution: injury from using worn drill bits or burs.Drill bits or burs could fall out during treatment and injure the patient.-> never use drill bits or burs with worn shafts.Caution: hazard from defective chucking system.The cutter or grinder could fall out and cause injury.-> pull on the cutter or grinder to check that the chucking system is okay and the cutter or grinder is securely held.When checking, inserting and removing, use gloves or a fingerstall to prevent an injury or infection.

Event Description

During a standard dental treatment the bur came loose from the instrument and dropped into patients mouth.Patient swallowed the bur.It has been reported that the patient has been sent to hospital.It was decided to wait until the bur passed the gastrointestinal tract on the natural way.Therefore there was no further medical care necessary and there was no injury to a person.

• Brand Name: SMARTTORQUE LUX S619 L
• Type of Device: DENTAL HANDPIECE
• Manufacturer (Section D): KAVO DENTAL GMBH; bismarckring 39; biberach / riss, bw 88400 ; GM 88400
• Manufacturer (Section G): KAVO DENTAL GMBH; bismarckring 39; biberach / riss, bw 88400 ; GM 88400
• Manufacturer Contact: klaus reisenauer ; bismarckring 39; biberach / riss, bw 88400 ; GM 88400 ; 735156
• MDR Report Key: 5706101
• MDR Text Key: 46801657
• Report Number: 3003637274-2016-00040
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K093341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 05/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Model Number: S619 L
• Device Catalogue Number: 1.008.1641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2015
• 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
• Patient Outcome(s): Hospitalization