MAUDE Adverse Event Report: MISONIX INC. NEXUS BONESCALPEL MICRO HOOK SHAVER & TUBESET; ULTRASONIC SURGICAL ASPIRATOR SYSTEM

Model Number	110-31-1210
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	07/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The nexus bonescalpel® micro hook shaver & tubeset, 110-31-1210 was reported to have caused bleeding to the patient after the surgeon lifted the shaver and caught a blood vessel.The subject shaver was not returned to misonix for evaluation because it was disposed of after case completion.Review of the inspection records for the microhook shaver reveals that there were no deviations found during in-process or final inspection of the device.We cannot determine a definitive root cause because the device was not returned for further investigation.
Event or Problem Description
Dr.(b)(6) was using the microshaver for a 3 level acdf.It was from c4-c7.He was usinf the microshaver on the second level when he lifted the shaver and caught a vessel.This caused bleeding instantaneously.

• Brand Name: NEXUS BONESCALPEL MICRO HOOK SHAVER & TUBESET
• Common Device Name: ULTRASONIC SURGICAL ASPIRATOR SYSTEM
• Manufacturer (Section D): MISONIX INC.; 1938 new highway; farmingdale NY 11735
• MDR Report Key: 12333435
• Report Number: 2435119-2021-00020
• Device Sequence Number: 2506380
• Product Code: LFL
• UDI-Device Identifier: 00841626102996
• UDI-Public: 00841626102996
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 08/17/2021

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: 110-31-1210
• Device Lot Number: 213055
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/27/2021
• Initial Report FDA Received Date: 08/17/2021
• 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