MAUDE Adverse Event Report: KAVO DENTAL GMBH SMARTTORQUE MINI S605 C; DENTAL HANDPIECE

Model Number S605 C

Device Problem Retraction Problem (1536)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/05/2023

Event Type  malfunction  

Event Description

During a treatment on crown on tooth #31 the bur shot off the handpiece mid prep and patient swallowed it.Patient was immediately referred to urgent care where an x-ray was taken of her chest and the bur was located.She was then referred to the emergency room.Dentist is unaware of procedure done at this time, was just informed that patient was discharged.The dental treatment was completed on monday (b)(6) 2023.Patient is doing well.

Manufacturer Narrative

The handpiece was not returned for analysis, customer denied doing so.Therefore, it is not possible to determine the root cause why the bur was not held properly.Various causes are possible, like worn clamping system, clamping system not well maintained, bur not correctly inserted, shaft diameter of bur matches not with specification of handpiece, etc.The ifu contains already several warnings and notes which advice how to maintain and use the handpiece correctly.It also informs about the correct specification of the bur shaft.It also states that prior to each treatment the correct seat of th bur should be checked.

• Brand Name: SMARTTORQUE MINI S605 C
• 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: 18019658
• MDR Text Key: 326685778
• Report Number: 3003637274-2023-00024
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 10/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: S605 C
• Device Catalogue Number: 1.008.1645
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2023
• 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