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

Model Number M8700 L

Device Problem Device Handling Problem (3265)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/21/2018

Event Type  malfunction  

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.To check if the used bur-type fulfills the requested specification stated in the ifu a sample was requested from the user.But dental office stated that they don't have one left and they don't use it anymore.Hence test of the third party tool was not possible.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.The 2.3 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.The 5.4 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.(b)(4).

Event Description

During filling to tooth# 19, the bur came out in patient's mouth.No injury to patient as it came out in mouth.Doctor tried to collect the bur, but bur was swallowed by patient.Office suggested to patient to go get x-rays to make sure there was no issue with bur.Office offered to pay for x-rays and any other care needed.Per dental assistance, office does not believe the patient went to get any x-ray or follow up care by anyone.No one from patient/family contacted office to pay for anything.

• Brand Name: MASTERTORQUE MINI LUX M8700 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
• MDR Report Key: 7788783
• MDR Text Key: 117615378
• Report Number: 3003637274-2018-00039
• 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: health professional,user faci
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 08/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M8700 L
• Device Catalogue Number: 3.001.0000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2017
• 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 Age: 17 YR