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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MISONIX, INC. NEXUS® STANDARD HANDPIECE; ULTRASONIC SURGICAL ASPIRATOR SYSTEM HANDPIECE
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MISONIX, INC. NEXUS® STANDARD HANDPIECE; ULTRASONIC SURGICAL ASPIRATOR SYSTEM HANDPIECE Back to Search Results
Model Number 100-21-0001
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/11/2022
Event Type  malfunction  
Event Description
On october 18, 2022, misonix llc., a bioventus co., received a product occurrence report on a nexus® standard handpiece, (part number 100-21-0001, serial number (b)(4)) that occurred on (b)(6) 2022, during a lumbar laminectomy and fusion.A serious injury to the patient or user was not reported; however, there was a delay in treatment greater than 15 minutes.Medical intervention required to preclude serious injury was not reported.Specifically, it was reported that "nexus generator did not recognize handpiece when handpiece was inserted.".
 
Manufacturer Narrative
On october 18, 2022, misonix llc., a bioventus co., received a product occurrence report on a nexus® standard handpiece, (part number 100-21-0001, serial number (b)(4)) that occurred on (b)(6) 2022, during a lumbar laminectomy and fusion.A serious injury to the patient or user was not reported; however, there was a delay in treatment greater than 15 minutes.Medical intervention required to preclude serious injury was not reported.Specifically, it was reported that "nexus generator did not recognize handpiece when handpiece was inserted." the device history record was reviewed for the nexus® standard handpiece, (part number 100-21-0001, serial number (b)(4)).Serial number (b)(4) was manufactured in accordance with the device master record.Inspection and test results met specifications.There were no deviations or exceptions noted.A review of post-market surveillance information involving the nexus standard handpiece, product number 100-21-0001 did not show any significant adverse trends.No other reports were received on the subject serial number (b)(4).The current frequency of product occurrence reports for the nexus standard handpiece not being recognized by the generator is within the frequency estimated in the original risk management report.Therefore, there is no change to the residual risk or risk-benefit ratio.The nexus® ifu contains the following warnings and cautions to mitigate harm from delay in treatment: warning: 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.Caution: the system check should always be done in advance of preparing patient for surgery to minimize risk to patient in case of system malfunction.Caution: it is strongly advised that a sterile backup handpiece be readily available in the operating room as insurance any contamination or malfunction of the handpiece used during surgery.The subject device has not yet been returned to misonix for evaluation; therefore, further investigation could not be conducted.Upon return a full engineering evaluation will be completed to establish possible root cause of the non-conformance.
 
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Brand Name
NEXUS® STANDARD HANDPIECE
Type of Device
ULTRASONIC SURGICAL ASPIRATOR SYSTEM HANDPIECE
Manufacturer (Section D)
MISONIX, INC.
1938 new hwy
farmingdale NY 11735
Manufacturer (Section G)
MISONIX, INC.
1938 new hwy
farmingdale NY 11735
Manufacturer Contact
john salerno
1938 new hwy
farmingdale, NY 11735
6319279172
MDR Report Key15818999
MDR Text Key304215904
Report Number2435119-2022-00008
Device Sequence Number1
Product Code LFL
Combination Product (y/n)N
Reporter Country CodeTD
PMA/PMN Number
K190610
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Non-Healthcare Professional
Remedial Action Repair
Type of Report Initial
Report Date 11/17/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/17/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number100-21-0001
Date Manufacturer Received10/18/2022
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
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