MAUDE Adverse Event Report: NAKANISHI INC. TI-MAX Z; DENTAL HANDPIECE

Model Number Z900KL

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

The bur was released from the handpiece unexpectedly during a procedure on a patient's tooth and landed at the back of the patient's throat.The bur was recovered by the doctor and the patient was not affected.The dental office could not identify which one of two possible handpieces this happened with so a report will be made for both.This is report # 2 of 2.Reference 2023-00001 for first report.

• Brand Name: TI-MAX Z
• Type of Device: DENTAL HANDPIECE
• Manufacturer (Section D): NAKANISHI INC.; 700 shimohinata; kanuma, tochigi 322-8 666; JA 322-8666
• MDR Report Key: 16269206
• MDR Text Key: 308441487
• Report Number: 1422375-2023-00002
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date: 01/18/2023,01/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: Z900KL
• Device Catalogue Number: P1113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/06/2023
• Device Age: 4 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 01/18/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1