MAUDE Adverse Event Report: NAKANISHI, INC. (NSK) NSK NRS2-Y; HANDPIECE, ROTARY BONE CUTTING

Model Number NRS2-Y

Device Problem Temperature Problem (3022)

Patient Problem Complaint, Ill-Defined (2331)

Event Type  malfunction  

Event Description

This mdr is being reported at this lime as part of our internal review of past complaint and service records.Due to the incident being in the past, we are limited in the information that we can obtain from the initial complainant.Event information: during treatment, head heated up and there was complaint that it was hot from a patient.Dentist did not inform nakanishi when this event occurred.Dentist would like nakanishi to check this handpiece.And nakanishi repaired this handpiece on (b)(6) 2013, then returned it to the dentist.

Manufacturer Narrative

Upon receipt from the dentist of the device involved in the mdr event, nakanishi conducted a failure analysis of the returned device that included an attempt to measure the temperature of the operating device.These activities arc described in more detail below: methodology used : nakanishi conducted a visual inspection of the returned device and performed a simple movement test.There were no visible abnormalities, such as cracks or debris, on the outside of the handpiece.Nakanishi measured the temperature of the head of the handpiece for several minutes of operation and did not observe an abnormal rise in temperature.Identification of the specific failure mode(s) and/or mechanism(s) and the associated device components involved: nakanishi disassembled the handpiece and performed a visual inspection of the inside parts.Nakanishi observed there was wear on the reduction gear, but nakanishi is not sure this wear could cause the handpiece head to overheat.Conclusions reached based on the investigation and analysis results.Nakanishi identified this heat up might be due to a lack of maintenance, then nakanishi returned this handpiece after overhaul to the dentist.

• Brand Name: NSK NRS2-Y
• Type of Device: HANDPIECE, ROTARY BONE CUTTING
• Manufacturer (Section D): NAKANISHI, INC. (NSK); 700 shimohinata; kanuma-shi, tochigi-ken 322- 8666; JA 322-8666
• Manufacturer (Section G): NAKANISHI, INC. (NSK); 700 shimohinata; kanuma-shi, tochigi-ken 322- 8666; JA 322-8666
• Manufacturer Contact: ken block ; 1201 richardson dr; suite 280; richardson, TX 75080 ; 9727674325
• MDR Report Key: 4640940
• MDR Text Key: 5618012
• Report Number: 9611253-2015-00042
• Device Sequence Number: 1
• Product Code: KMW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K970953
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 03/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: NRS2-Y
• Device Catalogue Number: C549001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2011
• 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