MAUDE Adverse Event Report: NAKANISHI, INC. (NSK) NSK SX-SU03; HANDPIECE, AIR-POWERED, DENTAL, PRODUCT CODE: EFB

Model Number SX-SU03

Device Problems Detachment Of Device Component (1104); Sticking (1597)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/14/2015

Event Type  Injury  

Event Description

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 distributor did not inform nakanishi of the detailed information about the patient.Complaint review: there were no previous repairs on file for this handpiece.Investigation: the handpiece was forwarded to the manufacturer (nakanishi) for an analysis and investigation on (b)(6) 2015.Nakanishi has requested additional information from the distributor and now is waiting for the information.Nakanishi will submit additional information as a follow-up report.

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 retention force of the operating device.These activities are described in more detail below: methodology used: a) nakanishi examined the device history records for the subject sx-su03(serial number (b)(4)).B) 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.C) nakanishi measured bur detachment force by setting a test bur in the handpiece and confirmed it was 17.7n.Nakanishi's acceptance criteria for the bur detachment force is 25.0n 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 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: 1.The handpiece had been used with the dirt and debris inside the chuck.2.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 cleaning instruction included in the user manual in order to prevent the dirt or debris accumulated inside the chuck.

• Brand Name: NSK SX-SU03
• Type of Device: HANDPIECE, AIR-POWERED, DENTAL, PRODUCT CODE: EFB
• 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. ste 280; richardson, TX 75080 ; 9724809554
• MDR Report Key: 4895940
• MDR Text Key: 20450361
• Report Number: 9611253-2015-00097
• 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: 06/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: SX-SU03
• Device Catalogue Number: P1002250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/24/2013
• 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