MAUDE Adverse Event Report: NAKANISHI INC. (NSK) NKS SG16B

Model Number SG16B

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 06/10/2013

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 dist, a dentist found that a part of diamond coating from a tip sg16b was missing after a procedure.The broken part of the diamond coating was found in the bone of the pt.The dist informed nakanishi that the broken part had been removed from the pt.Complaint review: there were no previous repairs for this handpiece.

Manufacturer Narrative

Investigation: the handpiece was forwarded to the manufacturer (nakanishi) for an analysis and investigation on (b)(6) 2013.Upon receipt from the dentist of the device involved in the mdr event, nakanishi conducted a failure analysis of the returned device by observing the fracture surface.Nakanishi determined it was a fracture caused by fatigue and ductibility.Nakanishi believes that the tip was used with the setting of the higher power than the rang nakanishi recommends.Nakanishi reminded the user of the recommended power range for the tip as labeled.Nakanishi confirmed that the tip has been used normally by this user.

• Brand Name: NKS SG16B
• 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; kanuma-shi, tochigi-ken 322-8-666 ; JA 322-8666 ; 9724809554
• MDR Report Key: 4805668
• MDR Text Key: 5918997
• Report Number: 9611253-2015-00062
• Device Sequence Number: 1
• Product Code: ELC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K073678
• 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: 05/22/2015

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: SG16B
• Device Catalogue Number: Z305129
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/11/2013
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/09/2013
• Initial Date FDA Received: 05/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other