MAUDE Adverse Event Report: NAKANISHI INC. NSK; HANDPIECE, AIR-POWERED, DENTAL

Model Number	Z900L
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The dentist refused to provide any information about patient.Further inspection of the handpiece involved in the adverse event for cause by (b)(6) is no longer possible because the handpiece was serviced by the distributor (nsk america) and returned to the user.Due to the device not being returned from the distributor, (b)(6) examined the device history record (dhr) for the subject z900l device [serial no.(b)(6)].As a result of the examination, the dhr indicated that no problems occurred during manufacturing and testing of the subject device.
Event or Problem Description
On (b)(6) , 2026, (b)(6) became aware of a patient's accidental ingestion of a dental bur through a complaint input into the complaint database by a distributor (nsk america).Details are as follows: - the event occurred on may 8, 2024.- a dentist was performing a dental procedure on a patient using the z900l handpiece (serial no.(b)(6).- during the procedure, the dental office was aware that the patient had swallowed the bur.- the dentist advised that the patient visit the er to have an x-ray as a precaution.The patient is reported to have visited the er and was released after they could not locate the bur in the x-ray images.- the patient did not complain of any issues at the time of the event and did have a follow-up visit with the dentist after the event at the dental office with no issues.- the dental office reported that after some time had passed the patient had gone to a second er and at that time something was found.The dental office has not disclosed what was found or what the nature of their patient's second visit to the er was for.Due to the lack of information provided, it is not clear if the visit was due to the bur that was swallowed in (b)(6) 2024 or if it is for some other issue.

• Brand Name: NSK
• Common Device Name: HANDPIECE, AIR-POWERED, DENTAL
• Manufacturer (Section D): NAKANISHI INC.; 700 shimohinata; kanuma-shi, tochigi-ken 322-8 666; JA 322-8666
• Manufacturer (Section G): NAKANISHI INC.; 700 shimohinata; kanuma-shi, tochigi-ken 322-8 666; JA 322-8666
• Manufacturer Contact: sean kaufman ; 1800 global parkway; hoffman estates, IL 60192 ; 2245128921
• MDR Report Key: 24492415
• Report Number: 9611253-2026-00008
• Device Sequence Number: 4966743
• Product Code: EFB
• UDI-Device Identifier: 04560264572683
• UDI-Public: (01)04560264572683
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K113655
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 03/03/2026

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: Z900L
• Device Catalogue Number: P1111
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/23/2020
• 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