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

Model Number X-SG93

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/14/2022

Event Type  malfunction  

Manufacturer Narrative

The same adverse event in this report has been reported to the fda separately by the initial importer, (b)(4), under report number 1422375-2022-00054.

Event Description

On december 2, 2022, nakanishi became aware of a malfunction of an nsk handpiece through a complaint input into the complaint database by a distributor ((b)(4)).Details are as follows: the event occurred around (b)(6) 2022 (the exact date is unknown).The dentist was performing a dental procedure on a patient using the x-sg93l handpiece (serial no.(b)(4)).During the procedure, the push button of the handpiece came off in the patient's mouth and the patient was not injured in the event.

Manufacturer Narrative

Upon receiving the device involved in the mdr event from the distributor, nakanishi conducted a failure analysis of the returned 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 x-sg93 device [abl10002].There were no problems observed during manufacturing or testing noted in the dhr.There were no records indicating nakanishi (the manufacturer) repaired the device since the device was shipped.Nakanishi received the repair records from nsk america (the distributor), which included the detailed information about the repair nsk america carried out.Nakanishi kept the repair records in a file.B) nakanishi conducted a visual inspection of the returned device and observed the following: - the push button was separated from the handpiece.- the bur mounted to the handpiece was broken.C) nakanishi disassembled the handpiece and conducted a visual inspection of the internal parts.Nakanishi observed that the push button and the press-fit ring were abraded.D) 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 identified the cause of the push button of the returned device was removing the press-fit ring out of the handpiece due to the combination of a strong impact on the device together with cutting vibration based on the findings in the visual inspection.B) nakanishi also considers that the mounted bur to the handpiece fractured due to a heavy load or strong impact applied to the returned device during cutting and increased cutting vibration.C) misuse by the user led to the above issue, which contributed to the reported event.D) in order to prevent a recurrence of the push button separation, nakanishi took the following actions: d.1) nakanishi reviewed the operation manual and reconfirmed the clarity and understandability of the instructions.D.2) nakanishi will report the above evaluation results to the distributor and directed the distributor to remind the user of the importance of using the device as instructed in the operation manual.

• 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: sean kaufman ; 1800 global parkway; hoffman estates, IL 60192 ; 2245128921
• MDR Report Key: 16030855
• MDR Text Key: 308536020
• Report Number: 9611253-2022-00086
• Device Sequence Number: 1
• Product Code: KMW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970953
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,Distributor
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: X-SG93
• Device Catalogue Number: C1007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2020
• 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