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

Model Number Z800KL

Device Problems Detachment of Device or Device Component (2907); Misassembly by Users (3133)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/09/2024

Event Type  Injury  

Event Description

On february 23, 2024, nakanishi became aware of a patient's accidental ingestion of a dental bur through a complaint input into the complaint database by a distributor (nsk america).Details are as follows: the event occurred on january 9, 2024.A dentist was performing a restorative filling preparation on the patient's teeth #22, 23 and 24 using the z800kl handpiece (serial no.(b)(6)).During the procedure, the bur came out unexpectedly and landed on the dorsal side of the patient's tongue, and the patient swallowed the bur.The dentist has had a follow up visit with the patient and is expected to have passed the bur without complication.

Manufacturer Narrative

The same adverse event in this report has been reported to the fda separately by the distributor, (b)(4), under report number 1422375-2024-00005.

Manufacturer Narrative

Upon receiving an email from the distributor (nsk america) stating that the distributor found that a counterfeit cartridge was incorporated in the handpiece involved in the adverse event and showing photos of the handpiece with the counterfeit cartridge, nakanishi reviewed the photos of the handpiece with the counterfeit cartridge which the distributor took and determined that the cartridge mounted to the handpiece was counterfeit based on the following reasons.The shape of the button and screw in the cartridge were different from the original nsk's cartridge.The shape of the dustproof disk in the cartridge was different from the original nsk's cartridge.Therefore, nakanishi was not able to conduct the failure analysis of the device involved in the event.In order to prevent a recurrence of the bur separation, nakanishi took the following actions: 1) nakanishi reviewed the operation manual and reconfirmed the warning not to disassemble nor tamper with the device.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: 18899812
• MDR Text Key: 337620099
• Report Number: 9611253-2024-00012
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113655
• 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: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: Z800KL
• Device Catalogue Number: P1112
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/25/2020
• 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
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 210 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White