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

Model Number	MAXIMA ELITE 2 CA
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
3007007357-2024-00024 after investigation, no defect was found, the overheating could not be reproduced.The contra-angle handpiece was well maintained on the outside and inside and works perfectly.
Event or Problem Description
Device was over heating during treatment of patient.No injuries or burns reported.

• Brand Name: HENRY SCHEIN
• Common Device Name: DENTAL HANDPIECE
• Manufacturer (Section D): W&H DENTALWERK BUERMOOS GMBH; ignaz-glaser-strasse 53; buermoss, 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: 20843640
• Report Number: 3011300255-2024-00007
• Device Sequence Number: 3928373
• Product Code: EFB
• UDI-Device Identifier: 00304040153857
• UDI-Public: (01)00304040153857
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/04/2024

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2024
• Initial Report FDA Received Date: 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2023
• 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: Female