MAUDE Adverse Event Report: MISONIX NEXUS BONESCALPEL MICRO HOOK MIS; ULTRASONIC SURGICAL ASPIRATOR SYSTEM

Model Number	110-31-2210
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	08/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information pending.
Event or Problem Description
Misonix sales representative states: "i was notified of this issue significantly after the case.Dr.(b)(6) said that on one of his patients he used the mis microhook shaver and where the black housing and silicone meet, caused a burn mark on the patient's skin.The patient has come to multiple follow up appointments and the burn does not seem to be healing at all.Dr.(b)(6) also said the stitches are not holding where the burn is.".

• Brand Name: NEXUS BONESCALPEL MICRO HOOK MIS
• Common Device Name: ULTRASONIC SURGICAL ASPIRATOR SYSTEM
• Manufacturer (Section D): MISONIX; 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: 12839509
• Report Number: 2435119-2021-00023
• Device Sequence Number: 11869567
• Product Code: LFL
• UDI-Device Identifier: 00841626103047
• UDI-Public: 00841626103047
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K190160
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 11/18/2021

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 Expiration Date: 03/28/2023
• Device Model Number: 110-31-2210
• Device Lot Number: 203078
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2021
• Initial Report FDA Received Date: 11/18/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown