BoneScalpel MXB-MIS-20LCRSRecalls & reported problems
Misonix, Inc. · BoneScalpel, 20mm Long CURVED Rigid Blunt Blade · Class U
All models of BoneScalpel (10)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00841626101487), received between Jul 28, 2021 and Jul 28, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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 16, 2026.
Most reported problems
Device problems
- Fracture1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
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 ↗
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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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