MAUDE Adverse Event Report: NAKANISHI INC. NSK; SCALER, ULTRASONIC

Model Number S20

Device Problems Break (1069); Fracture (1260); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/11/2016

Event Type  malfunction  

Manufacturer Narrative

On march 23, 2016, nakanishi asked the distributor to obtain the patient information from the dental office, and according to the distributor, the office did not have the information about the patient's weight.

Event Description

On march 18, 2016, an nsk air scaler tip, s20 (lot no.0f7) was returned from a distributor to nakanishi.There was a note coming with the tip referring to occurrence of the tip breakage.Details are as follows.The event occurred on (b)(6) 2016.The dentist was cleaning the tooth surface of a patient with the tip s20.During the procedure, the tip was suddenly broken.The patient did not swallow the broken tip.The patient was not anesthetized.Due to the patient not being injured, the dentist did not provide any treatment for the event to the patient.

Manufacturer Narrative

Upon receipt from a distributor of the device involved in the mdr event, nakanishi conducted a failure analysis of the returned device [160322-03-1].These activities are described in more detail below.Methodology used: nakanishi conducted a visual inspection of the returned device.Nakanishi observed breakage around the water irrigation hole on the tip.Nakanishi also confirmed fatigue/ductile fracture on the broken surface of the tip.Nakanishi took photographs of all the damages on the tip and kept them in a file.Conclusions reached based on the investigation and analysis results: nakanishi did not identify the cause of tip being broken because the above visual inspection is the only evaluation nakanishi can make with the returned device.Therefore, nakanishi is not able to reproduce the situation at the time of the event.In spite of the fact that nakanishi did not identify the cause, nakanishi considers the possibility from many years of experience that use of the s20 tip with excessive air pressure or beyond the maximum power level increases the tip vibration, which applies repeated stress to the tip.As a result, this may have contributed to a crack in the water irrigation hole, leading to the broken tip.In order to prevent a recurrence of the tip breakage, nakanishi took the following actions: since there is no operation manual available for the tip, nakanishi reviewed the operation manual for the ti-max s950kl, a handpiece used along with the s20 tip.In the review, nakanishi reconfirmed clarity and understandability of the instructions.Nakanishi reported the above evaluation results and possible cause to the dentist and reminded the dentist of the risk of using the tip with excessive air pressure or beyond the maximum power level.

• Brand Name: NSK
• Type of Device: SCALER, ULTRASONIC
• 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: ken block ; 1201 richardson dr.; suite 160; richardson, TX 75080 ; 9724809544
• MDR Report Key: 5569457
• MDR Text Key: 43032851
• Report Number: 9611253-2016-00014
• Device Sequence Number: 1
• Product Code: ELC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K991021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/19/2016

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: Dentist
• Device Model Number: S20
• Device Catalogue Number: Z252441
• Device Lot Number: 0F7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/18/2016
• Initial Date FDA Received: 04/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2015
• 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: 38 YR
• Patient Weight: 54