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
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2024
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3011300255-2024-00001
• Device Sequence Number: 18079844
• Product Code: EFB
• UDI-Device Identifier: J021300060001
• UDI-Public: J021300060001
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K162926
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/08/2024
• Supplement Date Received by Manufacturer: 02/08/2024
• Initial Report FDA Received Date: 03/04/2024
• Supplement Report FDA Received Date: 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown