MAUDE Adverse Event Report: W&H DENTALWERK BUERMOOS GMBH HENRY SCHEIN; DENTAL HANDPIECE

Model Number	MAXIMA ELITE 2 CA
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The cause of the incident is wear.The holding force is worn out after more than 24 months of use.It can also happen that the parts wear out more quickly with heavy use and low oil maintenance.According to the instructions for use, the user must check that the instruments are held securely and carry out a test run.
Event or Problem Description
Doctor was using the handpiece on the patient when the bur dislodged from the chuck and was swallowed by the patient.

• Brand Name: HENRY SCHEIN
• Common Device Name: DENTAL HANDPIECE
• Manufacturer (Section D): W&H DENTALWERK BUERMOOS GMBH; ignaz-glaser-strasse 53; buermoos, 5111 ; AU 5111
• Manufacturer Contact: gerhard weidler ; ignaz-glaser-strasse 53; buermoos, 5111 ; AU 5111
• MDR Report Key: 20470114
• Report Number: 3011300255-2024-00006
• Device Sequence Number: 7603670
• Product Code: EFB
• UDI-Device Identifier: 00304040153857
• UDI-Public: (01)00304040153857
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Distributor
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 10/17/2024

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: MAXIMA ELITE 2 CA
• Device Catalogue Number: HS: 570-2660 (W&H: 30431000)
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2024
• Initial Report FDA Received Date: 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2022
• 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