BoneScalpelRecalls & reported problems across all models
Misonix, Inc. · 10 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 26
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls
- 0
We found 10 models of BoneScalpel by Misonix, Inc. in the FDA's device registry (GUDID). Together they are named in 26 adverse event reports in the FDA's MAUDE database, received between Sep 12, 2017 and Nov 12, 2021 — classified as 8 injuries, 18 malfunctions.
The most frequently reported specific device problem is “Human-Device Interface Problem” (5 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Most reported BoneScalpel problems
Device problems
- Human-Device Interface Problem5
- Use of Device Problem5
- Fracture4
- Adverse Event Without Identified Device or Use Problem2
- Insufficient Device Problem Information2
- Electrical /Electronic Property Problem1
- Electrical Shorting1
- Electrostatic Discharge1
Patient problems
- No Information8
- No Consequences Or Impact To Patient6
- Burn, Thermal3
- Insufficient Information3
- Burn(s)2
- Disc Impingement1
- Foreign Body In Patient1
- Headache1
BoneScalpel models
10 models, most reported first. Each model has its own page with its reports, recalls and device details.
- BoneScalpel MXB-B1Instrument, Ultrasonic Surgical7 reports
- BoneScalpel BCM-GNInstrument, Ultrasonic Surgical4 reports
- BoneScalpel MXB-10Instrument, Ultrasonic Surgical4 reports
- BoneScalpel MXB-S1Instrument, Ultrasonic Surgical4 reports
- BoneScalpel MXB-20Instrument, Ultrasonic Surgical2 reports
- BoneScalpel BCM-HPInstrument, Ultrasonic Surgical1 report
- BoneScalpel MXB-S3Instrument, Ultrasonic Surgical1 report
- BoneScalpel MXB-TInstrument, Ultrasonic Surgical1 report
- BoneScalpel MXB-MIS-20LCRSInstrument, Ultrasonic Surgical1 report
- BoneScalpel MXB-MIS-S1Instrument, Ultrasonic Surgical1 report
Recent BoneScalpel adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionJul 28, 2021Fracture; Fracture
STÖCKLI MEDICAL AG REPORTED THE FOLLOWING: "BLADE WAS MOUNTED ON THE HANDPIECE AND THE OR STAFF STARTED WITH THE IRRIGATION. THE BLADE BROKE DURING THE FIRST IRRIGATION. WAS DONE BESIDE THE OR FIELD. NO CONTACT TO PATIENT." IN A FOLLOW-UP CALL WITH THE CLINIC, A MISONIX SALES REPRESENTATIVE STATED THAT THE NURSE CONFIRMED THAT NO ONE WAS INJURED.
Patient problems: Insufficient Information
MAUDE report 12242118 ↗MalfunctionJun 25, 2021Fluid/Blood Leak; Fluid/Blood Leak
ON MAY 26, 2021, MISONIX RECEIVED MEDWATCH REPORT NUMBER (B)(4) FILED BY (B)(6) MEDICAL CENTER OF A NON-CONFORMING IRRIGATION TUBESET (MXB-T). (B)(6) OF (B)(6) MEDICAL CENTER, (B)(6), REPORTED THE TUBING LEAKED WHEN SPIKED DURING A PROCEDURE ON (B)(6) 2021. THE IRRIGATION TUBESET WAS NOT USED ON THE PATIENT AND REPLACED WITH A NEW ONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12071333 ↗MalfunctionApr 23, 2021Overheating of Device; Overheating of Device
(B)(6) REPRESENTATIVE, (B)(6), PROVIDED A TRANSLATED INCIDENT REPORT TO MISONIX ON 03/25/2021. "POWER ON OF THE MISONIX BONESCALPEL HAND PIECE, AFTER HAVING PURGED THE IRRIGATION TUBING, THE HANDPIECE STARTED TO HEAT UP, BURNING THE SURGEON WHO WAS HOLDING IT, FORCING HIM TO PUT DOWN THE HAND PIECE WHICH STARTED TO MELT AND RELEASE SMOKE."
Patient problems: Insufficient Information
MAUDE report 11720146 ↗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 ↗MalfunctionSep 18, 2020Fracture; Fracture
THIS REPORT IS FOR THE BONE SCALPEL 4.4MM DIAMOND STANDARD SHAVER. THE CUSTOMER INDICATED THAT THERE WAS "A "LIMIT" MESSAGE ON CONSOLE AFTER MINIMAL USE OF 2 CONSECUTIVE BUR TIPS DURING A CASE WITH FRACTURES NOTED TO BOTH TIPS AT THE END OF THE CASE".
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10553673 ↗MalfunctionJul 28, 2020Infusion or Flow Problem; Infusion or Flow Problem
THE LEGAL AGENT REPORTED AN ADVERSE EVENT TO MISONIX INC. ON (B)(6) 2020 FOR A LUMBAR DISCECTOMY IN WHICH "THE WATER SUDDENLY DECREASED, LEADING TO A SUDDEN RISE IN TEMPREATURE OF THE ULTRASONIC BONE KNIFE AND SCALDING THE PATIENT" FOR ULTRASONIC OSTEOTOME SYSTEM P/N E-BC06.
Patient problems: Patient Problem/Medical Problem
MAUDE report 10332454 ↗MalfunctionJun 27, 2019Electrostatic Discharge; Electrostatic Discharge
CUSTOMER STATED PROBLEM: "1ST AND 2ND HANDPIECES NOT WORKING - HAND PLACED ON TOP OF GENERATOR AND PULLED OUT THE HANDPIECE AND RECEIVED SHOCK."
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8741811 ↗MalfunctionDec 20, 2018Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
CUSTOMER STATED PROBLEM AS, "THIS MACHINE HAS BEEN IN HOSPITAL TO BE CHECKED BEFORE USING WITH PATIENTS. THEY FOUND OUT THAT THERE IS ELECTRICITY LEAK FROM THE MACHINE 5406UA ( THEY ACCEPT MAX 5000UA). WE ARE NOT ABLE TO USE THIS MACHINE WITH PATIENTS. THIS MACHINE HAS NOT BEEN USED ON THAT HOSPITAL WITH PATIENTS TREATMENTS. THERE HAS BEEN ONLY DEMONSTRATION FOR THE STAFF."
Patient problems: No Patient Involvement
MAUDE report 8186908 ↗InjuryDec 13, 2018Material Fragmentation; Material Fragmentation
CUSTOMER STATED PROBLEM AS "THE TIP OF A THIN BONESCALPEL BLADE BROKE WHILE WE WERE USING IT IN THE OPERATING ROOM ON (B)(6) 2018. IT WAS IN HEAVY USE AT THE TIME - THE BREAKAGE OCCURRED DURING OUR 4TH MANDIBULAR OSTEOTOMY. WE WERE ABLE TO FIND ABOUT ½ OF THE TIP IN THE WOUND, BUT COULD NOT FIND THE OTHER HALF. ON POSTOP X-RAY, WE THINK WE SEE IT AS A SMALL METALLIC FRAGMENT. WE INFORMED THE PATIENT AND WE DO NOT FEEL THERE WILL BE ANY LONG-TERM CONSEQUENCE. "
Patient problems: Foreign Body In Patient
MAUDE report 8161337 ↗InjuryDec 12, 2018Temperature Problem; Temperature Problem
CUSTOMER STATED PROBLEM AS "THE DISPOSABLE HEATED UP TO THE POINT OF CREATING A THERMAL BURN THROUGH THE BLACK CONE ON OPEN TISSUE DURING THE CASE. THE TISSUE WAS AN ASHY BLACK COLOR AFTERWARD. THE BLACK NOSE CONE DIDN'T SHOW SIGNED OF MELTING."
Patient problems: Burn, Thermal
MAUDE report 8158065 ↗MalfunctionOct 11, 2018Fracture; Fracture
CUSTOMER STATED PROBLEM, "BLADE BROKE DURING USE AND CRACKED INTO 3 PIECES."
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7958730 ↗MalfunctionSep 26, 2018Fracture; Fracture
CUSTOMER STATED PROBLEM AS "BLADE CRACKED DURING SURGERY" AND CONSIDERED THIS AN ADVERSE EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7910236 ↗
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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