BoneScalpel MXB-S1Recalls & reported problems
Misonix, Inc. · BoneScalpel MicroHook, Standard Shaver · Class U
All models of BoneScalpel (10)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00841626101210), received between Sep 18, 2020 and Nov 12, 2021 — classified as 4 injuries.
The most frequently reported specific device problem is “Use of Device Problem” (4 reports).
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 16, 2026.
Most reported problems
Device problems
- Use of Device Problem4
- Excessive Heating1
Patient problems
- Burn, Thermal2
- Burn(s)1
- Insufficient Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryNov 12, 2021Use of Device Problem; Use of Device Problem
ON OCT 12, ORTHO COORDINATOR, (B)(4), REPORTED (TO MISONIX SALES REPRESENTATIVE) THAT DR. (B)(6) USED ONE OF OUR SHAVERS. HE APPARENTLY TOOK THE SHEATH OFF AND LEANED THE SHAVER ON THE INSIDE OF THE BODY CAVITY CAUSING THERMAL BURNS AT THE INCISION SITE.
Patient problems: Burn(s)
MAUDE report 12807367 ↗InjuryApr 23, 2021Use of Device Problem; Excessive Heating; Use of Device Problem; Excessive Heating
IT WAS REPORTED ON (B)(6) 2021 THE MXB-S1 DISPOSABLE HAD "BURNT THE PATIENT'S SKIN" DURING A PROCEDURE. (THE DEGREE OF THE PATIENT BURN WAS NOT INDICATED IN THE REPORT. THERE WAS NO REPORT OF MEDICAL INTERVENTION TO PREVENT SERIOUS INJURY.)
Patient problems: Insufficient Information
MAUDE report 11719680 ↗InjuryOct 7, 2020Use of Device Problem; Use of Device Problem
THE BONESCALPEL MICROHOOK STANDARD SHAVER, MXB-S1 WAS REPORTED TO HAVE BURNT THE PATIENT SKIN WITH A DURAL TEAR THAT WAS TREATED WITH SUTURES AND DURAL SEALANT.
Patient problems: Burn, Thermal
MAUDE report 10644984 ↗InjurySep 18, 2020Use of Device Problem; Use of Device Problem
THE BONE SCALPEL MICROHOOK STANDARD SHAVER, MXB-S1 WAS REPORTED TO "HAVE BURNT THE PATIENT SKIN" ON (B)(6) 2020.
Patient problems: Burn, Thermal
MAUDE report 10554577 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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