MAUDE Adverse Event Report: MISONIX INC NEXUS BONESCALPEL MICRO HOOK MIS SHAVER AND TUBESET; ULTASONIC SURGICAL ASPIRATOR SYSTEM, PRODUCT CODE" LFL

Model Number	110-31-2210
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	09/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event description: the sales representative reported suspected thermal damage to patient tissue while undergoing a 2 level acdf from c5 to c7.Evaluation: the investigation is ongoing as of the date of this report.
Event or Problem Description
Suspected thermal damage to patient tissue.

• Brand Name: NEXUS BONESCALPEL MICRO HOOK MIS SHAVER AND TUBESET
• Common Device Name: ULTASONIC SURGICAL ASPIRATOR SYSTEM, PRODUCT CODE" LFL
• Manufacturer (Section D): MISONIX INC; 1938 new highway; farmingdale NY 11735
• Manufacturer (Section G): MISONIX INC; 1938 new highway; farmingdale NY 11735
• Manufacturer Contact: john salerno ; 1938 new highway; farmingdale, NY 11735 ; 6319279123
• MDR Report Key: 12749041
• Report Number: 2435119-2021-00021
• Device Sequence Number: 3632263
• Product Code: LFL
• UDI-Device Identifier: 00841626103047
• UDI-Public: 00841626103047
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 110-31-2210
• Device Lot Number: 203158
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2021
• Initial Report FDA Received Date: 11/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown