MAUDE Adverse Event Report: NAKANISHI, INC. (NSK) NSK TIX-MU03; HANDPIECE, AIR-POWERED, DENTAL

Model Number TIX-MU03

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Complaint, Ill-Defined (2331)

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.Event summary: according to the dentist, a bur was detached from a handpiece during a treatment and the patient accidentally swallowed the bur.The doctor did not inform to our distributor of the detailed information such as date of event.Complaint review: there is no complaint review for this handpiece.Investigation: the handpiece was forwarded to the manufacturer (nakanishi) for an analysis and investigation on (b)(6) 2013.As of this report, no additional information has been received.

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 ((b)(4)).These activities are described in more detail below: methodology used: nakanishi examined the device history records for the subject tix-mu03 cartridge ((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 conducted retention force measurement by setting a test bur in the handpiece and confirmed it was 18.2n.Nakanishi's acceptance criteria for the retention forces 22.0n or above, indicating that the retention force of the subject handpiece had deteriorated; nakanishi disassembled the handpiece to observe the inside of the chuck.Nakanishi confirmed accumulated dirt on the inner periphery and the pin sliding surface of the chuck, whose images wer captured with photographs; nakanishi cleaned the chuck and took photographs of the cleaned parts of the chuck.Nakanishi reassembled the handpiece.Conclusions reached: accumulation of dirt inside the chuck caused the deterioration of the retention force of the chuck that caused the detachment of the bur.Insufficient cleaning maintenance by the user caused the accumulation of the dirt.Additionally, the user used a bur which is not specified for the use with the subject handpiece.Nakanishi provided the user instruction regarding the appropriate type of bur and cleaning maintenance to be used in a report date (b)(4) 2013.

• Brand Name: NSK TIX-MU03
• Type of Device: HANDPIECE, AIR-POWERED, DENTAL
• 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: 4719765
• MDR Text Key: 17575755
• Report Number: 9611253-2015-00061
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K113655
• 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: 04/08/2015

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: TIX-MU03
• Device Catalogue Number: PALX0111
• Device Lot Number: P067001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/29/2013
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/29/2013
• Initial Date FDA Received: 04/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2010
• 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