MAUDE Adverse Event Report: W&H DENTALWERK BUERMOOS GMBH MAXIMA ELITE; HANDPIECE

Model Number	MAXIMA ELITE 2 1:5
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	06/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
After several uses, the product heated up and burned three (3) patients.
Additional Manufacturer Narrative
Related report number: (b)(4).The complained contra-angle handpiece was examined by w&h and no technical fault on the part of w&h could be detected.Thus, the initial assessment (lack of maintenance) of the distributor as the cause of the strong heating can be confirmed as plausible.

• Brand Name: MAXIMA ELITE
• Common Device Name: HANDPIECE
• Manufacturer (Section D): W&H DENTALWERK BUERMOOS GMBH; ignaz-glaser-strasse 53; buermoos, 5111 ; AU 5111
• Manufacturer (Section G): 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: 17600814
• Report Number: 3011300255-2023-00005
• Device Sequence Number: 17719053
• Product Code: EFB
• UDI-Device Identifier: 00304040153857
• UDI-Public: 0100304040153857
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/22/2023

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 1:5
• Device Catalogue Number: 30431000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2023
• Initial Report FDA Received Date: 08/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2022
• 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: Male