MAUDE Adverse Event Report: KAVO DENTAL GMBH MASTERTORQUE MINI LUX M8700 L; DENTAL HANDPIECE

Model Number M8700 L

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/28/2020

Event Type  malfunction  

Manufacturer Narrative

Unfortunately, the adverse event was only reported after the repair had already been carried out.Therefore a detailed analysis was not possible anymore retrospectively.But the documented findings of the incoming inspection show that the speed and the retention force have been too low.This indicates that the ball bearings, and the chuck have been worn out.To avoid such issues, the instruction for use contains already following warnings and notes: 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.Safety checks may only be performed by trained service personnel.If the following defects occur, stop working and have the service personnel carry out repair work: malfunctions; damage; irregular running noise; excessive vibration; overheating; dental bur or diamond grinder is not firmly locked in the handpiece.Service and repair: following expiry of the warranty, check the cutter/grinder holding system and quick stop 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.Defined the service interval depending on the frequency of use.Inserting the milling tools or diamond grinders.Note: only use carbide cutters or diamond grinders that comply with en 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: max.21 mm; shaft clamping length: at least 9 mm; blade diameter: max.2 mm.Caution: hazard from defective chuck system.The cutter or grinder could fall out and cause injury.Pull on the dental burr or rips abrasives to check if the clamping system is functioning properly and that the tool is firmly clamped.Wear gloves, or a thimble to check, insert, or remove the bits to prevent injury and infection.

Event Description

The dentist was performing a dental procedure using a kavo master torque mini lux m8700 l dental handpiece when allegedly the dental bur separated from the handpiece and was swallowed by the patient.The patient was taken to the hospital and x-rays were taken which showed the object was ready to pass, and no further treatment was required.Follow up was made by the dental facility office manager on (b)(6) 2020 with the mother of the patient, she stated that the patient had passed the bur.There were no injuries reported.

• Brand Name: MASTERTORQUE MINI LUX M8700 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: 10905116
• MDR Text Key: 219570280
• Report Number: 3003637274-2020-00023
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M8700 L
• Device Catalogue Number: 3.001.0000
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2015
• 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): Other
• Patient Age: 4 YR