MAUDE Adverse Event Report: NAKANISHI INC. (NSK) TI-SU03 GC

Model Number TI-SU03 GC

Device Problems Detachment Of Device Component (1104); Entrapment of Device (1212)

Patient Problem No Information (3190)

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 info that we can obtain from the initial complainant.Event summary: according to the dentist, a bur detached from a handpiece during a treatment and the bur was stuck in the patient's gum.The dist did not inform nakanishi of the detailed info about the pt.Complaint review: there were no previous repairs on file for this handpiece.

Manufacturer Narrative

Investigation: the handpiece was forwarded to the manufacturer (nakanishi) for an analysis on (b)(4) 2013.This event occurred in (b)(6) but the similar products are marketed in the us under k113655.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 retention force of the operating device ((b)(4)).These activities are described in more detail below: methodology used: nakanishi examined the device history records for the subject ti-su03 gc (serial number (b)(4)).There were no problems observed during the manufacturing or testing noted in the dhr.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 bur detachment force by setting a test bur in the handpiece and confirmed it was 20.9n.Nakanishi's acceptance criteria for the bur detachment force is 22.0n or above, indicating that the bur detachment force of the subject handpiece had deteriorated.Nakanishi disassembled the handpiece to observe the inside of the chuck, compared to an unused new chuck and took photographs.Nakanishi observed the observed the accumulation of the dirt.Conclusion reached: the bur detached from the handpiece due to the deterioration of the bur retention torque that was caused by the accumulation of the dirt inside of the chuck.Nakanishi believes that there are two causes for the wear of the chuck: the handpiece had been used with the dirt and debris inside the chuck.The handpiece was used under the load and rotational speed that were higher than those specified with the retention capacity of the chuck.Nakanishi reminded the user of the instruction included in the user manual in order to prevent the dirt or debris accumulated inside the chuck.

• Brand Name: TI-SU03 GC
• Manufacturer (Section D): NAKANISHI INC. (NSK); 700 shimohinata; kanuma-shi, tochigi-ken 322- 8666; JA 322-8666
• Manufacturer (Section G): NAKANISH, INC. (NSK); 700 shimohinata; kanuma-shi, tochigi-ken 322- 8666; JA 322-8666
• Manufacturer Contact: ken block ; 1201 richardson dr.; ste 280; richardson, TX 75080 ; 9727674325
• MDR Report Key: 4805661
• MDR Text Key: 21179506
• Report Number: 9611253-2015-00066
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K962543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Service Personnel
• Type of Report: Initial
• Report Date: 05/21/2015

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?: No
• Device Operator: Other
• Device Model Number: TI-SU03 GC
• Device Catalogue Number: P058009
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/17/2013
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/17/2013
• Initial Date FDA Received: 05/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2009
• 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