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

Model Number M500L

Device Problems Detachment Of Device Component (1104); Unintended Ejection (1234); Mechanical Problem (1384); Detachment of Device or Device Component (2907)

Patient Problems Foreign Body In Patient (2687); Patient Problem/Medical Problem (2688); No Code Available (3191)

Event Date 04/04/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).- (b)(4).Is listed in and mr.(b)(4) because mr.(b)(4) is the official correspondent of both nakanishi inc.And (b)(4).The information received from (b)(4) is as follows.- on (b)(6) 2017, (b)(4) received an email from the dental office explaining all three devices were forwarded to the dealer prior to the initial reporting of the unconfirmed event to (b)(4) and was to be serviced by the dealer.- the dealer was contacted by the dental office manager upon receiving nsk's request to forward the device to (b)(4) and per the dental office manager.- the dealer forwarded the device directly to (b)(4).- on april 6, 2017, april 10, 2017, and april 11, 2017, (b)(4) contacted the dental office by phone and email to request patient information, but the dental office did not disclose the patient information.- no service history record was found for model m500l (serial number (b)(4)) at (b)(4).Nakanishi is submitting three separate mdrs for this event because the dentist referenced three devices that is a possibility that was in use at the time of the event.This mdr is related with mfr report #9611253-2017-00022 and mfr report #9611253-2017-00024 describing event or problem.

Event Description

On april 14, 2017, nakanishi received an email from a distributor ((b)(4)) describing a patient injury.Details are as follows.- on (b)(6) 2017, (b)(4) was made aware of an unconfirmed patient injury by an nsk sales representative.- the dentist contacted the nsk sales representative.- the dentist stated that a bur ejected from a handpiece device and the patient ingested the bur.- the event occurred on (b)(6) 2017.- the dentist also reported the device involved was not segregated at the time of the event and was placed back in stock by the dentist.- the device involved with patient can not be identified.- the dentist referenced three devices that were potentially in use at the time of the event and provided model number(s) and serial number(s) for each device as follows.A) m500l (serial number (b)(4)); b) m500l (serial number (b)(4)); c) m600l (serial number (b)(4)).- (b)(4) contacted the dental office to obtain more information, and the nsk patient information form was immediately forwarded to the dentist to be completed.

Manufacturer Narrative

Upon receiving the device involved in the mdr event from a distributor, (b)(4) conducted a failure analysis of the returned device [c170417-19].These activities are described in more detail below.Methodology used: (b)(4) examined the device history record and the repair history for the subject s-max m500l device [serial number (b)(4)].There were no problems observed during the manufacturing or testing noted in the dhr.There were no repair history records since the device was shipped.(b)(4) conducted a visual inspection of the returned device and observed numerous dents and cracks on the outside of the handpiece.(b)(4) then disassembled the handpiece and found that a counterfeit nsk cartridge was incorporated in the handpiece.(b)(4) determined the cartridge was not an nsk product are due to the following conditions: there is no dust-proof disc on the bur insertion side of the cartridge.The cartridge bears marking that the nsk cartridge does not have.The cartridge does not bear marking that the nsk cartridge has.Shape of the rotor differs from the nsk rotor.(b)(4) took photographs of the counterfeit nsk cartridge and kept them in a file.Conclusions reached based on the investigation and analysis results: (b)(4) identified that the cause of the bur coming off was the use of the counterfeit nsk cartridge by the operator.Failure to follow the instructions regarding cartridges compatible for use with the handpiece when replacing the cartridge contribute to the reported bur coming off.In order to prevent a recurrence of the bur coming off, (b)(4) took the following actions: (b)(4) reviewed the operation manual and reconfirmed clarity and understandability of the instructions.(b)(4) reported the above evaluation results to nsk america and directed nsk america to remind the user of the importance of following instructions in the operation manual and to explain how to avoid counterfeits.

• Brand Name: NSK
• 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. REGISTRATION NUMBER 9611253; mfr rp#9611253-2017-00023; 700 shimohinata; kanuma-shi,, tochigi-ken 322-8 666; JA 322-8666
• Manufacturer Contact: kenneth block ; 1201 richardson dr.; suite 160; richardson 75080 ; 9724809554
• MDR Report Key: 6541333
• MDR Text Key: 74369545
• Report Number: 9611253-2017-00023
• 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,health profession
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 04/12/2017,07/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Model Number: M500L
• Device Catalogue Number: P1001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/04/2017
• Device Age: 2 YR
• Event Location: Other
• Date Report to Manufacturer: 04/12/2017
• Date Manufacturer Received: 06/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2014
• 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