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

Model Number 110-31-2210

Device Problems Use of Device Problem (1670); Excessive Heating (4030)

Patient Problem Insufficient Information (4580)

Event Date 12/18/2020

Event Type  Injury  

Manufacturer Narrative

The initial report was for seven (7) patient burns using the misonix nexus bonescalpel micro hook mis shaver and tubeset (part number 110-31-2210).During follow-up the initial reporter clarified the seven (7) events as follows; five (5) events were 2nd degree burns to patient's skin at that incision during lumbar mis applications.No medical intervention was required.Two (2) events were 3rd degree burns to patient skin at the surgical incision during cervical application.Medical intervention to excise the burnt skin was required.Misonix is filing seven (7) mdrs respectively.This report is for one (1) second degree burn to patient's skin at that incision during lumbar mis applications.At a subsequent teleconference held on (b)(6) 2020 with the initial reporter, misonix made recommendations on revising the surgeon's surgical technique consistent with the product labeling to prevent thermal injury, tissue necrosis and patient burns.On march 25, 2021 a follow-up with the initial reporter indicated he has not had a re-occurnace of patient burns.The instructions for use section 1.2 warnings for the nexus standard handpiece includes the following warnings: tip and irrigation temperatures may exceed the tissue necrosis point if insufficient irrigation flow rates are used.For hard tissue removal, set the irrigation flowrate to a setting no less than the comparable vibration setting.For example, if the vibration setting is 70, a minimum flow setting of 70% should be used.Additional external irrigation, e.G., by administering sterile saline with a syringe over the distal tip portion, may be necessary for removal of very dense, hard osseous structures.Tissue necrosis may result if tip is not moved relative to tissue.A continuous, lateral sweeping motion is recommended in order to minimize contact duration with the ultrasonic tip and minimize heat build-up.When lateral motion is not possible withdraw and re-insert tip frequently.Contact to vibrating elements like extension and ultrasonic tip may cause burns and should be avoided by all means.The handpiece should only be held at the black housing area.An optional, protective silicone sleeve, included with certain tips, reduces the risk of thermal damage but does not eliminate it.Contact with the silicone sleeve should be avoided or kept brief with minimal amount of contact pressure.Pressure and extended exposure can still result in excessive frictional heat and cause burns.Heat is being generated at the tip/tissue interface.A continuous, lateral sweeping motion is recommended for general bone/tissue removal in order to minimize contact duration with the ultrasonic tip and minimize the temperature increase.The instructions for use section 1.3 cautions for the nexus standard handpiece includes the following cautions: insufficient irrigation and high tip pressure (loading) under extended exposure, e.G., in tight cavities, are to be avoided while removing hard tissue.It is recommended to withdraw and re-insert the ultrasonic tips (e.G., blades & shavers) repeatedly to reestablish adequate cooling and lubrication.Additional external irrigation, e.G., by administering sterile saline with a syringe over the distal tip portion, may be necessary when removing very dense, hard osseous structures.Prime the irrigation tubing prior to use.At all times ensure that the irrigation flows towards the handpiece when footswitch is depressed.If no irrigation is flowing, cease use until flow is restored.

Event Description

On (b)(6) 2020, the initial reporter reported patient burns during spinal surgery to a misonix sales representative while using the nexus bonescalpel micro hook mis shaver and tubeset (part number 110-31-2210).On follow-up, the initial reporter stated; five (5) events were 2nd degree burns to patient's skin at that incision during lumbar mis applications.No medical intervention was required.Two (2) events were 3rd degree burns to patient skin at the surgical incision during cervical application.Medical intervention to excise the burnt skin was required.This report is for one (1) second degree burn to patient's skin at that incision during lumbar mis applications.

• Brand Name: NEXUS BONESCALPEL MICRO HOOK MIS SHAVER & TUBESET
• Type of Device: ULTRASONIC SURGICAL ASPIRATOR SYSTEM
• Manufacturer (Section D): MISONIX INC.; 1938 new highway; farmingdale NY 11735
• Manufacturer Contact: john salerno ; 1938 new highway; farmingdale, NY 11735
• MDR Report Key: 11720218
• MDR Text Key: 263827173
• Report Number: 2435119-2021-00008
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 00084162610304
• UDI-Public: 0084162610304
• 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: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 04/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 110-31-2210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other