MAUDE Adverse Event Report: MISONIX, INC NEXUS SONASTAR SHORT HANDPIECE; ULTRASONIC SURGICAL ASPIRATOR SYSTEM

Model Number	100-24-0001
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During a craniotomy the surgeon noted the handpiece started smoking.The handpiece was swapped for another and surgery continued.No injuries were reported.There was a visible bubble on the cover of the handpiece.The handpiece being used was a nexus sonastar shot handpiece, part number 100-24-0001.
Additional Manufacturer Narrative
The reporter, a misonix sales representative, reported a nexus sonastar short handpiece, part number 100-24-0001 started smoking during surgery.The surgery was a craniotomy.The reporter indicated that there was a bubble in the cover of the handpiece.No patient or user injury was reported.The product was returned and an evaluation verified the complaint.The device history record was reviewed and no anomalies that can be associated with the complaint incident were observed.The handpiece met all specifications prior to release to commerce.Testing and inspection of the returned handpiece indicated electrical arcing.The potential root cause of electrical arcing was a manufacturing defect.Corrective and preventive action was implemented to prevent a recurrence of the manufacturing defect.A trend analysis of similar occurrences for nexus handpieces does not indicate an increasing trend.Therefore, there is no change to the nexus risk management report.Misonix will continue to monitor reports for any change in trends.

• Brand Name: NEXUS SONASTAR SHORT HANDPIECE
• Common Device Name: ULTRASONIC SURGICAL ASPIRATOR SYSTEM
• Manufacturer (Section D): MISONIX, INC; 1938 new highway; farmingdale NY 11735
• Manufacturer (Section G): MISONIX; 1938 new highway; farmingdale NY 11735
• Manufacturer Contact: john salerno ; 1938 new highway; farmingdale, NY 11735 ; 6319279123
• MDR Report Key: 12920153
• Report Number: 2435119-2021-00024
• Device Sequence Number: 20111758
• Product Code: LFL
• UDI-Device Identifier: 00841626102538
• UDI-Public: 00841626102538
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K190610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 100-24-0001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown