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

Model Number TI-MAX X450L

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 08/04/2023

Event Type  malfunction  

Event Description

On august 29, 2023, nakanishi became aware of a malfunction of a nsk handpiece through a complaint input into the complaint database by a distributor (nsk america).Details are as follows: the event occurred on (b)(4) 2023.A dentist was performing a wisdom tooth extraction procedure on a patient using the ti-max x450l handpiece (serial no.(b)(6)).During the procedure, the push button and internal spring came off from the headcap of the handpiece unexpectedly while inside the patient's mouth.Both of the parts were recovered by the dentist and there was no injury to the patient.

Manufacturer Narrative

The same adverse event in this report has been reported to the fda separately by the distributor, (b)(4), under report number (b)(4).

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 ti-max x450l device [(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 a visual inspection of the device and observed the following: - the push button and internal spring were separated from the device.- the retaining screw was loosened.- the bur returned together with the device was not completely mounted to the device.C) nakanishi disassembled the device and conducted a visual inspection of the internal parts.Nakanishi observed the following: - the bearing and bearing retainer were soiled and abraded.- there were contact marks between the headcap and the push button.D) nakanishi measured the size of the bur returned with the cartridge.The maximum diameter of the working portion was 1.50mm in the measurement, which is out of the device specification (1.00mm).Nakanishi also observed that the working portion of the bur was cracked and that the shank was soiled and scratched.E) 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 that the cause of the push button separation was retaining screw loosening due to the combination of a strong impact on the device together with cutting vibration.Nakanishi considers the possibility from many years of experience and based on the findings in the visual inspection, that the runout due to the abraded bearing, the push button pressed during rotation, incomplete mounting and use of the out-of-specification bur could increase the cutting vibration.B) misuse by the user led to the above issue, which contributed to the reported event.C) in order to prevent a recurrence of the push button loosening/separation, nakanishi took the following actions: c.1) nakanishi reviewed the operation manual and reconfirmed the clarity and understandability of the instructions.C.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, 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: 17786357
• MDR Text Key: 323909892
• Report Number: 9611253-2023-00055
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K112024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TI-MAX X450L
• Device Catalogue Number: P1078
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2023
• Initial Date FDA Received: 09/20/2023
• Supplement Dates Manufacturer Received: 12/20/2023
• Supplement Dates FDA Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2021
• 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