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

Model Number SGA-E2S

Device Problems Nonstandard Device (1420); Overheating of Device (1437); Temperature Problem (3022)

Patient Problems Burn(s) (1757); Swelling (2091); Injury (2348); Patient Problem/Medical Problem (2688)

Event Date 02/07/2020

Event Type  Injury  

Event Description

On february 28, 2020, nakanishi became aware of a handpiece overheating through a complaint input into the complaint database by a distributor (nsk america).Details are as follows: the event occurred on (b)(6) 2020.A dentist was performing a 3rd molar extraction on the patient using the sga-e2s handpiece (serial no.(b)(4)).The patient was under general anesthesia.During the procedure, the dentist found a blister approximately the size of a pea on the corner of the patient's right lower lip.The injury was cleaned and neosporin was administered to the area.The dentist has conducted a follow up with the patient and the injury has healed normally.No further medical treatment was required for this injury.

Manufacturer Narrative

Upon receiving the device involved in the mdr event from the distributor, nakanishi conducted a failure analysis of the returned device that included measuring the operating temperature of the 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 [serial no.(b)(6) ].There were no problems observed during manufacturing or testing noted in the dhr.There were also no repair history records since the device was shipped.B) nakanishi conducted temperature testing of the returned device in the following manner: b.1) temperature sensors were attached to the exterior of the device at various test points.This included the point most proximal to the patient (testing point (1)) and points further toward the distal end of the device (testing points (2) through (4)).The test setup was prepared to take temperature measurements at all points simultaneously, including a reference measurement at ambient room temperature.B.2) nakanishi attached a thermocouple (sensor to measure temperature) to each of the testing points.Nakanishi rotated the device's motor at 40,000 min-1, which is the maximum rpm for the motor that drives the handpiece (80,000 min-1 for the handpiece), with water spray, and measured the exothermic response.B.3) nakanishi measured the temperature rise of the returned handpiece set at 80,000 min-1 (motor revolution 40,000 min-1).Nakanishi observed an abnormal temperature rise at test points (1) and (2) a few seconds into the test.Temperature measurements 51 seconds after the start of the test were as follows: - test point (1): 79.4 degrees c - test point (2): 65.5 degrees c - test point (3): 30.4 degrees c - test point (4): 30.3 degrees c the rise in temperature was so sudden that the test was concluded 51 seconds into the planned 5-minute evaluation period.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 a great amount of debris on the bearing and other internal parts.B) nakanishi took photographs of all of the disassembled parts and kept them in investigation report (b)(4).Conclusions reached based on the investigation and analysis results: a) nakanishi identified that the cause of the overheating of the returned device was abnormal resistance during rotation caused by the soiled bearing.The ingress of undesirable materials caused the bearing to be soiled.B) a lack of maintenance caused the accumulation of debris on the internal parts, which caused debris ingress into the bearing during rotation.This contributed to the handpiece overheating.C) in order to prevent a recurrence of the handpiece overheating, nakanishi took the following actions: c.1) nakanishi reviewed the operation manual and reconfirmed the clarity and understandability of the instructions.C.2) nakanishi reported the above evaluation results to nsk america and directed nsk america to remind the user of the importance of maintenance, 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
• MDR Report Key: 9876451
• MDR Text Key: 196769694
• Report Number: 9611253-2020-00012
• Device Sequence Number: 1
• Product Code: KMW
• Combination Product (y/n): N
• PMA/PMN Number: K171155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2020
• 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 Returned to Manufacturer: 03/25/2020
• Date Manufacturer Received: 04/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 9611253-060818-001-R
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 17 YR
• Patient Weight: 59