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

Model Number X-SG65L

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 07/22/2020

Event Type  Injury  

Manufacturer Narrative

Upon receiving the device involved in the mdr event, 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: nakanishi examined the device history record and the repair history for the subject x-sg65l device [serial no.(b)(4)].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.Nakanishi conducted temperature testing of the returned device in the following manner: 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.Nakanishi attached a thermocouple (sensor to measure temperature) to each of the testing points.Nakanishi rotated the device's motor at 40,000 min-1, which is the maximum rpm for the motor that drives the handpiece (40,000 min-1 for the handpiece), with water spray, and measured the exothermic response.Nakanishi measured the temperature rise of the returned handpiece set at 40,000 min-1 (motor revolution 40,000 min-1).Nakanishi observed rises in temperature at the testing points as shown below; however, the temperatures were not high enough to cause a burn injury.Temperature measurements 5 minutes into the test were as follows: test point (1): 28.3 degrees c, test point (2): 28.1 degrees c, test point (3): 28.3 degrees c, test point (4): 27.8 degrees c.Identification of the specific failure mode(s) and/or mechanism(s) of the associated device components was conducted as follows: nakanishi disassembled the handpiece and performed a visual inspection of the internal parts.Nakanishi observed debris in the chuck.Nakanishi took photographs of all the disassembled parts and kept them in investigation report #(b)(4).Conclusions reached based on the investigation and analysis results: nakanishi could not identify the exact cause of overheating of the returned device because nakanishi was not able to replicate the temperature rise at the time of the event.The only abnormality nakanishi observed during the evaluation was debris in the chuck during the visual inspection.Nakanishi did not identify the cause, but based on the findings in the visual inspection, as well as many years of experience, nakanishi considers the possibility that the cause of the handpiece overheating was abnormal resistance during rotation due to the soiled internal part caused by temporary ingress of foreign materials such as saline/blood, or residual abrasive powder.A lack of maintenance caused debris ingress into the internal parts, which contributed to the handpiece overheating.In order to prevent a recurrence of the handpiece overheating, nakanishi took the following actions: nakanishi reviewed the operation manual and reconfirmed clarity and understandability of the instructions.Nakanishi will report the above evaluation results to the dentist and remind the dentist of the importance of maintenance and checking of the handpiece prior to use to prevent overheating as instructed in the operation manual.

Event Description

On (b)(6) 2020, nakanishi was contacted by a hospital about an nsk handpiece overheating.The detailed information is as follows: the event occurred on (b)(6) 2020.The dentist was performing a dental procedure using the x-sg65l handpiece (serial no.: (b)(4)).The patient was under general anesthesia.During the procedure, the bur rotation speed was not sufficiently increased, which led to a 1cm x 1 cm burn in the patient's mouth.The dentist applied ointment to the wound.

• Brand Name: NSK
• Type of Device: 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: kenneth block ; 800 e campbell rd.; suite 202; richardson, TX 75081 ; 9724809554
• MDR Report Key: 11001024
• MDR Text Key: 221716615
• Report Number: 9611253-2020-00047
• Device Sequence Number: 1
• Product Code: KMW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K970953
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: X-SG65L
• Device Catalogue Number: H1009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 34 YR
• Patient Weight: 46