MAUDE Adverse Event Report: NAKANISHI INC. FORZA M5; HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL

Model Number FORZA M5

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/05/2022

Event Type  Injury  

Manufacturer Narrative

The distributor refused to provide information about the patient's weight, ethnicity, and race.According to the distributor, the handpiece involved in the adverse event is no longer available for investigation because the distributor repaired the device and returned the device to the user.Due to the device not being returned from the distributor, nakanishi examined the device history record (dhr) for the subject forza m5 device [serial no.(b)(4)].As a result of the examination, the dhr indicated that no problems occurred during manufacturing and testing of the subject device.

Event Description

On (b)(6), 2022, nakanishi received an email from a distributor (brasseler usa) about an adverse event in which an nsk handpiece had been involved.According to the distributor, there are three devices suspected to be involved in the event, but the dentist could not identify which one of the devices actually caused the following event.Therefore, nakanishi is submitting three separate mdrs for this event.This mdr is regarding the handpiece with the serial number (b)(4).Details are as follows.The event occurred on (b)(6), 2022.The dentist was sectioning a patient's tooth using a forza m5 handpiece (serial no.Is (b)(4)).During the procedure, the fg surgical bur, which is an out-of-specification bur, attached to the handpiece fractured in half and broke the patient's adjacent porcelain crown.The instruction not to use an fg surgical bur is provided in the operation manual.

• Brand Name: FORZA M5
• Type of Device: HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, 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: sean kaufman ; 1800 global parkway; hoffman estates, IL 60192 ; 2245128921
• MDR Report Key: 13630283
• MDR Text Key: 289731398
• Report Number: 9611253-2022-00014
• Device Sequence Number: 1
• Product Code: EGS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182999
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 03/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FORZA M5
• Device Catalogue Number: 5027608U0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2021
• 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: 63 YR
• Patient Sex: Male