MAUDE Adverse Event Report: NAKANISHI INC. NSK; HANDPIECE, ROTARY BONE CUTTING

Model Number SGA-E2S

Device Problems Nonstandard Device (1420); Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 03/30/2022

Event Type  Injury  

Manufacturer Narrative

The same adverse event in this report has been reported to the fda separately by the distributor, (b)(4) america corporation, under report number 1422375-2022-00013.The dentist refused to provide the patient's weight.

Event Description

On april 19, 2022, nakanishi became aware of a handpiece overheating through a complaint input into the complaint database by a distributor ((b)(4) america).Details are as follows: the event occurred on (b)(6) 2022.The dentist was performing a wisdom tooth extraction on a patient using the sga-e2s handpiece (serial no.(b)(4)).The dentist was sectioning tooth #32 when the bur suddenly stopped rotating.The dentist immediately removed the device from the patients' mouth, then the dentist observed a serious burn on the patient's lower lip.The patient was under deep sedation at the time of the injury.The dentist had a follow up with the patient and the injury was reported to be healing normally at that time.

Manufacturer Narrative

Upon receiving the device involved in the mdr event, nakanishi conducted a failure analysis of the returned device [report no.(b)(4)].These activities are described in more detail below.Methodology used: a) nakanishi examined the device history record and the repair history for the subject sga-e2s device [(b)(4)].There were no problems observed during manufacturing or testing noted in the dhr.There were no repair history records since the device was shipped.B) nakanishi connected the handpiece to the motor and tried to rotate the motor.However, the handpiece was locked, and the motor did not rotate at all.Therefore, nakanishi was not able to conduct temperature testing of the device.Identification of the specific failure mode(s) and/or mechanism(s) of the associated device components was conducted as follows: a) nakanishi disassembled the handpiece and performed a visual inspection of the internal parts.Nakanishi observed that the bearing was soiled, discolored, and broken.B) nakanishi took photographs of all the disassembled parts and kept them in the investigation report no.(b)(4).Conclusions reached based on the investigation and analysis results: a) nakanishi could not replicate the temperature increase from the event, but based on the findings in the visual inspection, nakanishi identified that the cause of the handpiece overheating was abnormal resistance during rotation due to the broken bearing.B) nakanishi considers the possibility from many years of experience that the cause of the broken bearing was the ingress of undesirable materials into the bearing, leading to abrasion.C) a lack of maintenance caused the accumulation of debris on the internal parts, which contributed to the handpiece overheating.D) in order to prevent a recurrence of the handpiece overheating, nakanishi took the following actions: d.1) nakanishi reviewed the operation manual and reconfirmed the clarity and understandability of the instructions.D.2) nakanishi reported the above evaluation results to the dentist and reminded the dentist of the importance of maintenance and checking of the handpiece prior to use to prevent overheating, as instructed in the operation manual.

• Brand Name: NSK
• Type of Device: HANDPIECE, ROTARY BONE CUTTING
• 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: 14350674
• MDR Text Key: 291348187
• Report Number: 9611253-2022-00024
• Device Sequence Number: 1
• Product Code: KMW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,Distributor
• Reporter Occupation: Administrator/Supervisor
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 08/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SGA-E2S
• Device Catalogue Number: H265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 04/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 9611253-060818-001-R
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 15 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American