neXus 110-31-2210Recalls & reported problems
Misonix, Inc. · neXus BoneScalpel® Micro Hook MIS Shaver & Tubeset · Class U
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841626103047), received between Nov 3, 2021 and Nov 18, 2021 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Insufficient Device Problem Information1
- Output Problem1
Patient problems
- Superficial (First Degree) Burn1
- Unspecified Tissue Injury1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 18, 2021Output Problem
MISONIX SALES REPRESENTATIVE STATES: "I WAS NOTIFIED OF THIS ISSUE SIGNIFICANTLY AFTER THE CASE. DR. (B)(6) SAID THAT ON ONE OF HIS PATIENTS HE USED THE MIS MICROHOOK SHAVER AND WHERE THE BLACK HOUSING AND SILICONE MEET, CAUSED A BURN MARK ON THE PATIENT'S SKIN. THE PATIENT HAS COME TO MULTIPLE FOLLOW UP APPOINTMENTS AND THE BURN DOES NOT SEEM TO BE HEALING AT ALL. DR. (B)(6) ALSO SAID THE STITCHES ARE NOT HOLDING WHERE THE BURN IS."
Patient problems: Superficial (First Degree) Burn
MAUDE report 12839509 ↗MalfunctionNov 3, 2021Insufficient Device Problem Information
SUSPECTED THERMAL DAMAGE TO PATIENT TISSUE.
Patient problems: Unspecified Tissue Injury
MAUDE report 12749041 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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