MAUDE Adverse Event Report: NAKANISHI INC. NSK; MOTOR, DRILL, ELECTRIC

Model Number	PDS-2RFUL-50
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Dural Tear (1417)
Date of Event	03/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On march 18, 2026, nakanishi received an email from a distributor (nsk europe) and received information that a surgeon injured dura mater using an nsk surgical bur.The details nakanishi obtained are as follows.- the event occurred on march 17, 2026.- the surgeon was performing a craniotomy procedure using the pds-2rful-50 surgical bur (lot no.25x1) together with a p300 standard attachment (serial no.Unknown).- the surgeon reported a dual tear during the procedure.- the surgeon also reported that the patient is on good health condition, and that no post-operative issue in relation with the incident has been reported.
Additional Manufacturer Narrative
Nakanishi is still trying to obtain information about the event, including information about the patient.
Additional Manufacturer Narrative
On april 20, 2026, nakanishi received an email from the distributor (b)(4) stating that the surgical bur involved in the adverse event had already been disposed of by the user, and that the handpiece used together with the bur could not be returned because the user was unable to identify which handpiece had been used.Therefore, further inspection of the surgical bur by nakanishi to determine the cause of the adverse event is no longer possible.Due to the surgical bur not being returned from the distributor, nakanishi examined the device history record (dhr) for the subject pds-2rful-50 bur "[lot no.25x1]".As a result of the examination, the dhr indicated that no problems occurred during the manufacturing and testing of the subject bur.On may 13, 2026, nakanishi received another email from the distributor (b)(4) stating that the distributor was unable to obtain any additional information about the event, including information about the patient from the user.

• Brand Name: NSK
• Common Device Name: MOTOR, DRILL, ELECTRIC
• 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: 24854052
• Report Number: 9611253-2026-00015
• Device Sequence Number: 16075489
• Product Code: HBC
• UDI-Device Identifier: 04589551353446
• UDI-Public: (01)04589551353446(17)300930(10)25X1
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K132264
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2026

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: PDS-2RFUL-50
• Device Catalogue Number: PDS-2RFUL-50
• Device Lot Number: 25X1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2026
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 04/13/2026
• Supplement Report FDA Received Date: 05/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/17/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown