MAUDE Adverse Event Report: KAVO DENTAL GMBH EXPERTTORQUE LUX E679 L; DENTAL AIR-POWERED HANDPIECE

Model Number E679 L

Device Problems Detachment of Device or Device Component (2907); Device Handling Problem (3265)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/17/2021

Event Type  malfunction  

Manufacturer Narrative

The dentist (user) did not return the handpiece for evaluation or repair.Therefor an analysis was not possible.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 can injure patients, users and third parties.Use the device and components only if there is no damage on the outside.Check to make sure 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, dental bur or diamonds is not firmly locked in the handpiece.Caution: use of burs with worn or damaged shafts.Risk of injury, tool may fall out during treatment.Never use burs with damaged or worn shafts.Notice: tool shaft slips inside the chuck due to excessive speed of the tool or abrupt engagement of the tool.Property damage to tool shaft and chuck system, reduction of the service life of tool and chuck system.Do not operate the tool at a higher speed than recommended by the manufacturer.Notice: use of burs with worn or damaged shafts.Property damage to the chuck system, tool is difficult or impossible to remove from the chuck system.Do not use burs with damaged or worn shafts.

Event Description

During bonding attachments for suremile aligners the bur came loose and fell into patients mouth who swallowed it.The bur (skinny pointed diamond) is an accessory from another manufacturer which we are not aware of.The dentist decided to send patient to get an x-ray to identify the location.After taken xray patient emailed everything is good.There was no injury to patient and no medical treatment neccessary.

• Brand Name: EXPERTTORQUE LUX E679 L
• Type of Device: DENTAL AIR-POWERED 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: 12638065
• MDR Text Key: 276584424
• Report Number: 3003637274-2021-00039
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073478
• 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: 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E679 L
• Device Catalogue Number: 10069200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2018
• 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