MAUDE Adverse Event Report: W&H DENTALWERK BÜRMOOS GMBH TG-97 LM SYNEA FUSION TURBINE; TG-97 LM HIGHSPEED HANDPIECE

Model Number TG-97 LM

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

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

Event Date 02/07/2024

Event Type  Injury  

Event Description

The doctor was prepping posterior tooth with w&h high speed tg-97 lm using a 330 carbide bur.While cutting the crown with the highspeed handpiece the bur slipped out of the handpiece, past through the dry shield down the patients throat.The procedure was immediately stopped and the patient was instructed to go to the emergency room.The personnel of the emergency room sent him to the hospital and after locating the bur in his stomach by x-ray, the patient had an emergency endoscopy where the bur was retrieved.

Manufacturer Narrative

After evaluation of both tg-97 lm highspeed handpieces no device problem was detected.The tensioning system in particular has no faults.Both highspeed handpieces were in almost new condition, visually and technically.It is possible that when using a drill that does not comply with the iso 1797 standard, the drill may slowly move out during treatment.The swallowed drill was not available for evaluation.

Event Description

The doctor was prepping postieror tooth with w&h high speed tg-97 lm using a 330 carbide bur.While cutting the crown with the highspeed handpiece the bur slipped out of the handpiece, past through the dry shield down the patients throat.The procedure was immediately stopped and the patient was instructed to go to the er.The personnel of the er sent him to the hospital and after locating the bur in his stomach by x-ray, the patient had an emergency endoscopy where the bur was retrieved.

• Brand Name: TG-97 LM SYNEA FUSION TURBINE
• Type of Device: TG-97 LM HIGHSPEED HANDPIECE
• Manufacturer (Section D): W&H DENTALWERK BÜRMOOS GMBH; ignaz-glaser strasse 53; buermoos, 5111 ; AU 5111
• Manufacturer (Section G): W&H DENTALWEK BUERMOOS; ignaz-glaser strasse 53; buermoos, 5111 ; AU 5111
• Manufacturer Contact: gerhard weidler ; ignaz-glaser strasse 53; buermoos, 5111 ; AU 5111
• MDR Report Key: 18826043
• MDR Text Key: 336776928
• Report Number: 3011300255-2024-00001
• Device Sequence Number: 1
• Product Code: EFB
• UDI-Device Identifier: J021300060001
• UDI-Public: J021300060001
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162926
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TG-97 LM
• Device Catalogue Number: 30006000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2023
• 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