MAUDE Adverse Event Report: NAKANISHI INC. TI-MAX Z; DENTAL HANDPIECE

Model Number	Z95L
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Tooth Fracture (2428)
Date of Event	05/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Nsk america was made aware of an adverse event that occurred in may of last year (2025) while investigating another adverse event involving the same handpiece.(ref.1422375-2026-00014).The doctor reported that the bur that they were using bent suddenly and struck the patient's tooth causing it to fracture.The patient has received restorative treatment for the damaged tooth without needing additional treatment because of the incident.This incident was never reported to nsk america and the doctor continued to use the device after the event.No patient information has been provided at the time of this report, and a follow-up report will be made if this information becomes available.

• Brand Name: TI-MAX Z
• Common Device Name: DENTAL HANDPIECE
• Manufacturer (Section D): NAKANISHI INC.; 700 shimohinata; kanuma-shi, tochigi-ken 322-8 666; JA 322-8666
• MDR Report Key: 25059790
• Report Number: 1422375-2026-00015
• Device Sequence Number: 9353742
• Product Code: EGS
• UDI-Device Identifier: 04560264575448
• UDI-Public: 04560264575448
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 05/01/2026
• Report Date (Section F): 05/01/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: Z95L
• Device Catalogue Number: C1034
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/27/2026
• Device Age: 1 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 05/01/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/01/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male