MAUDE Adverse Event Report: MISONIX INC NEXUS 10MM BLUNT BLADE; ULTRASONIC SURGICAL SYSTEM

Model Number 110-31-1110

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/18/2019

Event Type  malfunction  

Manufacturer Narrative

Event description: the sales representative reported on a deformation and breakage of 10mm blunt blades during a multi-level lumbar fusion procedure.The first blade was distorted, and the scrub tech swapped out for new blade.Part of the second blade broke off into the patient.This extended the case by 1-2 hours.The broken blade was undetected by x-ray or computed tomography (ct) scan.A serious injury to the patient or user was not reported.Patient information and clinical history was not provided.The user stated they are filing an fda maude system.Evaluation: the investigation is ongoing as of the date of this report.The broken and deformed blades subject of this complaint were not returned to misonix from the customer.The nexus ifu contains the following warnings and cautions: warnings: the nexus ultrasonic surgical aspirator system is intended to be used in various types of invasive, surgical procedures.There may be indirect danger to the patient should the device fail during the procedure.It is recommended that the facility follows its back-up equipment protocols.Contact of the ultrasonic tip or the exposed extension with metal, surgical instruments or other objects during ultrasound must be avoided.Such contact can damage the ultrasonic components very easily and may result in compromised performance, including failure.Discard any extensions or tips that show signs of damages like gouges, nicks or fractures.Ultrasonic tips can break under excessive use in extreme conditions, e.G.When cutting for extended / duration in tight cavities with limited lateral motion.The tip could break into two or more fragments with the main fragment remaining attached to the handpiece.All fragments must be retrieved immediately from the surgical site.The fragments should be checked to ensure that no further pieces are missing.It is possible that a fragment is propelled outside of the surgical cavity.Diagnostic imaging, such as x-ray, must be used if a fragment cannot be found to confirm that the broken piece is outside of the surgical cavity.Breakage of ultrasonic tips will result in sharp edges that can be harmful to soft tissue even without activation of ultrasound.Tips can bend or deform before they actually brake.Tips showing signs of deformation or cracking should be replaced immediately since tip breakage is otherwise imminent.Do not bend or twist the ultrasonic tips since it reduces the structural integrity and can result in tip breakage during use.Dispose of deformed or broken tips immediately in a sharps container.Caution: contact of the ultrasonic tip or the exposed extension with metal, surgical instruments or other objects during ultrasound use must be avoided.Such contact can damage the ultrasonic components very easily and may result in compromised performance, including failure.Discard any extensions or tips that show signs of damages like gouges, nicks or fractures.External aspiration may be used but it is recommended that a plastic suction tip should be used when in proximity with the probe tip.

Event Description

The [sales rep] reported a deformation and breakage of 10mm blunt blades during a multi-level lumbar fusion procedure.The first blade was distorted, and the scrub tech swapped out for new blade.Part of the second blade broke off into the patient.This extended the case by 1-2 hours.The broken blade was undetected by x-ray or computed tomography (ct) scan.

• Brand Name: NEXUS 10MM BLUNT BLADE
• Type of Device: ULTRASONIC SURGICAL SYSTEM
• Manufacturer (Section D): MISONIX INC; 1938 new highway; farmingdale NY 11735
• Manufacturer (Section G): MISONIX INC; 1938 new highway; farmingdale NY 11735
• Manufacturer Contact: jenny cunniffe ; 1938 new highway; farmingdale, NY 11735 ; 6319279147
• MDR Report Key: 9473417
• MDR Text Key: 197804722
• Report Number: 2435119-2019-00005
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 00084162610295
• UDI-Public: 0084162610295
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190160
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 110-31-1110
• Device Lot Number: 193012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1