MAUDE Adverse Event Report: W&H DENTALWERK BUERMOOS GMBH WG-99 LT; SYNEA FUSION HANDPIECE 1:5

Model Number	30007000
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Aspiration/Inhalation (1725)
Date of Event	04/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Crown lengthening surgery on palatal aspect of tooth 15 was happening.The entire bur (tungsten carbide round bur hm1/5, hager & meisinger gmbh) dislodged out of the handpiece and fell in the throat.The patient was immediately notified and at completion of the procedure was immediately sent for radiographs to see whether it had entered the chest or stomach.Later it was found from the radiographs that bur was located in the patient's chest.Patient was then referred to the respiratory team at (b)(6) hospital for further management.Unfortunately, after an attempt at bronchoscopy the tip of the bur was visible but was unable to be retrieved, so the team elected to leave it in place and monitor for symptoms.
Additional Manufacturer Narrative
After inspection of the affected handpiece by the new zealand sponsor (ivoclar vivadent limited), no defect was identified in the device.

• Brand Name: WG-99 LT
• Common Device Name: SYNEA FUSION HANDPIECE 1:5
• Manufacturer (Section D): W&H DENTALWERK BUERMOOS GMBH; ignaz-glaser strasse 53; buermoos, salzburg 5111 ; AU 5111
• Manufacturer Contact: gerhard weidler ; werner bader strasse 1; buermoos, salzburg 5111 ; AU 5111
• MDR Report Key: 25443755
• Report Number: 3003755849-2026-00002
• Device Sequence Number: 9533398
• Product Code: EFB
• UDI-Device Identifier: J021300070001
• UDI-Public: J021300070001
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/09/2026

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: 30007000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/30/2016
• 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