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

Model Number TI-MAX X450QD

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907); Device Fell (4014)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687); Patient Problem/Medical Problem (2688)

Event Date 11/13/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6), but similar products are marketed in the us under k112024.

Event Description

On (b)(6) 2018, nakanishi received an e-mail from a distributor (b)(4) about a problem with an nsk dental product.Details are as follows.The event occurred on (b)(6) 2018.A dentist was extracting an impacted tooth from the patient's mouth using the ti-max x450qd handpiece (serial no.(b)(4)).There were no abnormalities in the device observed prior to use.During the procedure, the headcap and cartridge came out of the handpiece and dropped in the patient's mouth.The dentist immediately retrieved the parts, and the patient was not injured in the event.

Manufacturer Narrative

Upon receiving the device involved in the mdr event, nakanishi conducted a failure analysis of the returned device [(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 x450qd device [serial number (b)(4)].There were no problems observed during the 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 returned device.There were no visible abnormalities on the threads of the headcap and head, such as abrasion or deformation.Nakanishi also confirmed that the headcap was released by hand.C) nakanishi observed whether or not a headcap attached to the returned handpiece would loosen by rotating without load and then cutting a melamine plate at the maximum speed ((b)(4)).There was no headcap loosening observed in the evaluation.Conclusions reached based on the investigation and analysis results: although nakanishi could not replicate the reported event, nakanishi considers the possibility, from similar phenomena that nsk has experienced in the past, that the combination of a strong impact on the device with cutting vibration could result in the reported headcap loosening/detachment.Failure to check the headcap tightness before each use as instructed in the operation manual contributes to the headcap loosening/detachment.In order to prevent a recurrence of the headcap loosening/coming off, nakanishi took the following actions: nakanishi reviewed the operation manual and reconfirmed clarity and understandability of the instructions.Nakanishi reported the above evaluation results to nsk shanghai and directed nsk shanghai to remind the user of the importance of checking the handpiece before use 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
• MDR Report Key: 8140068
• MDR Text Key: 130326245
• Report Number: 9611253-2018-00061
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 12/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TI-MAX X450QD
• Device Catalogue Number: P1086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2018
• Date Manufacturer Received: 11/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 40 YR
• Patient Weight: 70