MAUDE Adverse Event Report: MISONIX, INC. NEXUS® STANDARD HANDPIECE; ULTRASONIC SURGICAL ASPIRATOR SYSTEM HANDPIECE

Model Number 100-21-0001

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Nerve Damage (1979)

Event Date 04/14/2023

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2023, misonix® llc., a bioventus® co., received a product occurrence report for an event that occurred on (b)(6) 2023, while using a nexus® standard handpiece (p/n: 100-21-0001) with a nexus® bonescalpel® 25mm, blunt blade & tubeset kit (p/n 110-31-1125) during a lumbar laminectomy.Specifically, the report indicated the patient suffered nerve damage during the case and is experiencing numbness.However, the surgeon stated that he did not feel strongly the nexus® bonescalpel® caused the problem but rather the patient anatomy with adhesion contributed to the adverse event.Delay in treatment was not reported.A malfunction was not reported.During the investigation of this report the sales representative who submitted the product occurrence report indicated the following: the patient had unique anatomy.The surgeon performing the procedure could not indicate or say that the nerve root damage was 100% caused by the nexus® bonescalpel®.The doctor believes there was a cross connection between nerve roots.When he "roofed" the lamina after the laminectomy it might have pulled on the actual nerve root itself.The surgeon is an experienced user of the nexus® system and has been observed numerous times in cases correctly following the surgical technique required per the ifu.Follow up on the patient condition with the surgeon indicated the patient is still experiencing numbness but is recovering well and showing signs of strength.The surgeon indicated the patient "has odd sensory changes that seem to be partially improved, no weakness that i can tell and no radicular pain".The subject handpiece serial number and the probe kit lot number were not reported and the devices were not returned.Therefore, further evaluation is not possible.A review of post-market surveillance involving the nexus® standard handpiece, product number 100-21-0001 did not show any significant adverse trends for postoperative neurological deficits.The current frequency of product occurrence reports for the nexus® standard handpiece is within the frequency estimated in the original risk management report.Therefore, there is no change to the residual risk or risk-benefit ratio.

Event Description

On (b)(6) 2023, misonix® llc., a bioventus® co., received a product occurrence report for an event that occurred on (b)(6) 2023, while using a nexus® standard handpiece (p/n: 100-21-0001) with a nexus® bonescalpel® 25mm, blunt blade & tubeset kit (p/n 110-31-1125) during a lumbar laminectomy.Specifically, the report indicated the patient suffered nerve damage during the case and is experiencing numbness.However, the surgeon stated that he did not feel strongly the nexus® bonescalpel® caused the problem but rather the patient anatomy with adhesion contributed to the adverse event.Delay in treatment was not reported.A malfunction was not reported.

• Brand Name: NEXUS® STANDARD HANDPIECE
• Type of Device: ULTRASONIC SURGICAL ASPIRATOR SYSTEM HANDPIECE
• 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 ; 6319279172
• MDR Report Key: 16950254
• MDR Text Key: 315443093
• Report Number: 2435119-2023-00008
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 190160
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 05/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 100-21-0001
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other