MAUDE Adverse Event Report: NAKANISHI INC. MASTER STANDARD UP; HANDPIECE, AIR-POWERED, DENTAL

Model Number MASTER STANDARD UP

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/26/2016

Event Type  malfunction  

Manufacturer Narrative

This report 9611253-2016-00027 is regarding the event notified to fda with the report number mw5062084 which was attached to a letter from mr.(b)(6) dated may 20, 2016.

Event Description

Nakanishi received an email from (b)(4) on may 11, 2016 that states the dentist was working on a patient to prepare a tooth for a composite filling when bur came apart in the patient's mouth.The bur was recovered from the patient's mouth by the dentist and the patient was not injured.

Manufacturer Narrative

Upon receiving the device involved in the event, nakanishi conducted a failure analysis of the returned device: methodology used: a) nakanishi examined the device history record for the subject master standard up (serial number (b)(4)).There were no problems observed during the manufacturing or testing noted in the dhr.- the dhr shows that the serial number of the cartridge installed in the body was (b)(4).B) nakanishi disassembled the handpiece and performed a visual inspection of the parts.- nakanishi determined that the wear on the inside of the head cap occurred when the push button was pushed during rotation.- nakanishi removed the cartridge from the handpiece.- nakanishi found that the cartridge was not the original nakanishi cartridge.- the bur holder had a different stroke and shape than the original nakanishi cartridge.- the nakanishi original cartridge case has a marking, but there was no marking on the returned cartridge.- nakanishi took photographs of the disassembled parts and kept them in a file.C) conclusion reached based on the investigation and analysis result: - the handpiece can be exchanged for a cartridge on the user's side.Nakanishi determined that the user purchased a non-nakanishi cartridge and built it into the handpiece.- nakanishi concluded that the root cause of this problem was the use of an imitation cartridge and the user's mishandling.The distributor did not disclose the patient's name or weight.

• Brand Name: MASTER STANDARD UP
• Type of Device: HANDPIECE, AIR-POWERED, DENTAL
• 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 ; 1201 richardson dr.; suite 160; richardson, TX 75080 ; 9724809554
• MDR Report Key: 5700928
• MDR Text Key: 47940720
• Report Number: 9611253-2016-00027
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Model Number: MASTER STANDARD UP
• Device Catalogue Number: 1008267
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2009
• 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
• Patient Age: 24 YR