MAUDE Adverse Event Report: NAKANISHI INC. NSK; HANDPIECE, ROTARY BONE CUTTING

Model Number	SGS-E2S
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	07/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The dentist refused to provide information about the patient's weight.
Event or Problem Description
On july 16, 2025, nakanishi became aware of a handpiece overheating through a complaint input into the complaint database by a distributor (nsk america).Details are as follows: the event occurred on july 7, 2025.The dentist was performing a third molar extraction procedure on a patient using the sgs-e2s handpiece (serial no.(b)(6) during the procedure, the handpiece overheated abnormally, and the patient received a thermal burn to their external cheek.The burn occurred when the dentist rested the handpiece on the patient's cheek during the procedure, not realizing that it had become very hot while in use.The patient was referred to a dermatologist for further treatment of the injury and is expected to heal normally with little to no scarring.
Additional Manufacturer Narrative
Upon receiving the device involved in the mdr event from the distributor, nakanishi conducted a failure analysis of the returned device, which included measuring the operating temperature of the device [report no.(b)(4)].These activities are described in more detail below.Methodology used: a) nakanishi examined the device history record and the repair history for the subject sgs-e2s device [serial no.(b)(6)].There were no problems observed during manufacturing or testing noted in the dhr.There were also no repair history records since the device was shipped.B) nakanishi conducted temperature testing of the returned device in the following manner: b.1) temperature sensors were attached to the exterior of the device at various test points.This included the point most proximal to the patient (testing point (1)) and points further toward the distal end of the device (testing points (2) through (4)).The test setup was prepared to take temperature measurements at all points simultaneously, including a reference measurement at ambient room temperature.B.2) nakanishi attached a thermocouple (sensor to measure temperature) to each of the testing points.Nakanishi rotated the device's motor at 40,000min-1, which is the maximum rpm for the motor that drives the handpiece (80,000min-1 for the handpiece), without water spray, and measured the exothermic response.B.3) nakanishi measured the temperature rise of the returned handpiece set at 80,000min-1 (motor revolution 40,000min-1).Nakanishi observed an abnormal temperature rise at the test point (1) 50 seconds into the test.Temperature measurements about 1 minute 30 seconds after the start of the test were as follows: test point (1): 93.0 degrees c, test point (2): 62.8 degrees c, test point (3): 33.3 degrees c, test point (4): 35.2 degrees c.The increase in temperature was so sudden that the test was concluded about 1 minute 30 seconds into the planned 5-mimute evaluation period.Identification of the specific failure mode(s) and/or mechanism(s) of the associated device components was conducted as follows: a) nakanishi disassembled the handpiece and performed a visual inspection of the internal parts.Nakanishi observed that the bearings were soiled, discolored, and broken.B) nakanishi took photographs of all the disassembled parts and kept them in the investigation report no.(b)(4).Conclusions reached based on the investigation and analysis results: a) nakanishi determined that the cause of the handpiece overheating was abnormal resistance during rotation due to the broken bearings.Nakanishi considers the possibility from many years of experience that the cause of the broken bearings was the ingress of undesirable materials into the bearing, leading to abrasion.B) a lack of maintenance caused the accumulation of debris on the internal parts, which caused debris ingress into the bearing during rotation.This contributed to the handpiece overheating.C) in order to prevent a recurrence of the handpiece overheating, nakanishi took the following actions: c.1) nakanishi reviewed the operation manual and reconfirmed the clarity and understandability of the instructions.C.2) nakanishi reported the above evaluation results to the distributor and directed the distributor to remind the user of the importance of maintenance as instructed in the operation manual.

• Brand Name: NSK
• Common Device Name: HANDPIECE, ROTARY BONE CUTTING
• 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: 22656976
• Report Number: 9611253-2025-00043
• Device Sequence Number: 8446614
• Product Code: KMW
• UDI-Device Identifier: 04560264556294
• UDI-Public: (01)04560264556294
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K171155
• 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: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2025

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: SGS-E2S
• Device Catalogue Number: H266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2025
• Supplement Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 9611253-060818-001-R
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 21 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic
• Patient Race: White