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

Model Number EOM TITANIUM TURBINE X-SL

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Skin Tears (2516)

Event Date 07/11/2023

Event Type  Injury  

Event Description

On july 28, 2023, nakanishi received an e-mail from an oem about a malfunction of an nsk handpiece.The details nakanishi obtained are as follows: the event occurred on (b)(6) 2023.The dentist was performing a dental procedure on a patient using the eom titanium turbine x-sl handpiece (serial no.(b)(6)) and the led coupling (serial no.(b)(6)).The patient was not under anesthesia.During the procedure, the handpiece came out of the coupling and cut the inside of the patient's mouth.The dentist applied azunol ointment to the injury.The injury has healed normally without any need for additional medical treatment.According to the dentist, there were no abnormalities observed in the device prior to use.

Manufacturer Narrative

This event occurred in japan, but similar products are marketed in the us under k113655.The dentist refused to provide information about the patient's weight.

Manufacturer Narrative

Upon receiving the device involved in the mdr event, 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 eom titanium turbine x-sl device [a8y01425].There were no problems observed during manufacturing or testing noted in the dhr.The repair history showed 3 service records since the device was shipped.The repair details are as follows: october 2015: the cartridge was replaced.March 2020.The cartridge was replaced.April 2020.The device was overhauled.No components were replaced.With respect to the repairs in the above list, the service record indicate that nakanishi performed all of the necessary operation checks and confirmed that all of the criteria were met.B) nakanishi performed a manual reproducibility test.There was no problem connecting the returned handpiece with the led coupling [serial no.(b)(6)] returned together with the handpiece.Nakanishi then pulled the handpiece by hand from the coupling without pulling the connector ring of the coupling to see whether or not the handpiece was removed from the coupling.Nakanishi did not observe the handpiece removal as reported by the user.C) nakanishi supplied the handpiece with air with the manufacturer's recommended pressure (0.3mpa) and stopped supplying repeatedly to replicate the reported phenomenon.Separation of the handpiece from the coupling was not observed during the test.D) nakanishi evaluated pull length of the handpiece by pulling the handpiece from the coupling using force specified in the specifications (100n or greater).The handpiece did not separate from the coupling.E) nakanishi conducted a visual inspection of the handpiece and coupling and observed that the joints of the handpiece and coupling were slightly soiled and that foreign materials were attached on the handpiece and coupling.F) 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 could not identify the exact cause of the handpiece separating from the coupling because nakanishi was not able to replicate the phenomenon during testing and did not observe any abnormalities in the visual inspection.B) in spite of the fact that nakanishi did not identify the cause, nakanishi considers the possibility from many years of experience in the lock release direction by external factors or that the connection was temporarily unstable due to foreign materials.C) carelessness by the user causes erroneous operation leading to the reported handpiece separation.D) in order to prevent a recurrence of the handpiece separation from the coupling, 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 dentist and remind the dentist of the importance o0f 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: 17569570
• MDR Text Key: 321402058
• Report Number: 9611253-2023-00051
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/25/2023

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
• Device Operator: Health Professional
• Device Model Number: EOM TITANIUM TURBINE X-SL
• Device Catalogue Number: P496003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 07/28/2023
• Initial Date FDA Received: 08/17/2023
• Supplement Dates Manufacturer Received: 10/10/2023
• Supplement Dates FDA Received: 10/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2008
• 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: 59 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian