MAUDE Adverse Event Report: NAKANISHI, INC. NSK; HANDPIECE, ROTARY BONE CUTTING

Model Number SGA-E2G

Device Problem Overheating of Device (1437)

Patient Problem Burn, Thermal (2530)

Event Type  Injury  

Event Description

This mdr is being reported at this time as part of our internal review of past complaints 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.Nakanishi received a handpiece for repair from nsk america.There was a note included in the package saying that the handpiece caused a burn to a pt due to overheating.Further details of the adverse event are unk.

Manufacturer Narrative

Upon receipt from nsk america of the device involved in the mdr event, nakanishi conducted a failure analysis of the returned device.Methodology used: nakanishi disassembled the handpiece and performed a visual inspection of the inside parts.Nakanishi observed the following problems: rust, damage and dirt in the spindle; damage in the bearings; dirt on the tip of the handpiece.Conclusions reached based on the investigation and analysis results: nakanishi identified that the cause of overheating of the returned device was due to dirt/damages of the inside part; a lack of maintenance causes dirt/damage of the inside parts.The dirt/damage observed caused abnormal rotation resistance, which would result in the handpiece overheating; in order to prevent the recurrence, nakanishi directed nsk america to remind the user of the maintenance instruction included in the user manual.Se.

Manufacturer Narrative

On july 20, 2019, nakanishi was informed by the distributor (nam) that nam had taken the following actions as a part of the ifu recall activities.On december 13, 2018, nam sent the updated operation manuals that contain the detailed reprocessing method to the dental office to prevent the devices from overheating.On december 17, 2018, nam confirmed the receipt of the operation manuals by the dentist through usps certified receipt.

• Brand Name: NSK
• Type of Device: HANDPIECE, ROTARY BONE CUTTING
• 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: kenneth block ; 800 e campbell rd.; suite 202; richardson, TX 75081 ; 9724809554
• MDR Report Key: 4850444
• MDR Text Key: 19743782
• Report Number: 9611253-2015-00022
• Device Sequence Number: 1
• Product Code: KMW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 08/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: SGA-E2G
• Device Catalogue Number: H184
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/01/2012
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/20/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 9611253-060818-001-R
• Patient Sequence Number: 1
• Patient Outcome(s): Other