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

Model Number M8700 L

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/17/2018

Event Type  Injury  

Manufacturer Narrative

The handpiece was tested according to the valid specification.Especially the retention force for the tool.There was no deviation found.If the tool shank diameter and length corresponds with the specified values, all parameters are ok.No fault was detectable at the product.The tools which get used are in general third party products and get chosen by the user.To ensure that they fulfill the necessary specification and that they get used and inserted in the correct way, the instruction for use contains several notes and warnings.Accessories and combination with other equipment: use of un-authorised accessories or un-authorised modifications of the device could lead to injury.Only use accessories that have been approved for combination with the product by the manufacturer.Only use accessories that are equipped with standardised interfaces.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.Warning: use of unauthorised dental burs or diamond grinders.Injury to the patient or damage to the medical device.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 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

On (b)(6) 2018 during a filling procedure, the bur came loose in mouth and was swallowed.A flame finishing bur was used during procedure.Patient went to his physician and had 2 x-rays performed.Bur was in the large intestines when 2 x-ray was performed in physician's office.He also was going to travel for a wedding and doctor advised he have 1 more x-ray during his trip to verify it passed.Barb (office manager) believes bur passed without issue.Patient has not called dentist office since he left for the trip.

Manufacturer Narrative

The initial report was by mistake only sent in the name of the manufacturer, but should also have been sent in the name of the importer.With this follow up report the necessary entries have been correted and added as necessary.(b)(4).

Manufacturer Narrative

By mistake the wrong importer# has been supplied - with this follow up it has been corrected.Exemption number e2010020.(b)(4).

• Brand Name: MASTERTORQUE MINI LUX M8700 L
• Type of Device: DENTAL HANDPIECE
• Manufacturer (Section D): KAVO DENTAL GMBH; bismarckring 39; bw 88400 ; GM 88400
• MDR Report Key: 7284990
• MDR Text Key: 100774143
• Report Number: 3003637274-2018-00004
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• PMA/PMN Number: K130560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 02/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Model Number: M8700 L
• Device Catalogue Number: 3.001.0000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2018
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 02/21/2018
• Device Age: 2 MO
• Event Location: Other
• Date Report to Manufacturer: 01/26/2018
• Date Manufacturer Received: 01/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR