BoneScalpel MXB-S3Recalls & reported problems
Misonix, Inc. · BoneScalpel 4.4mm Diamond, Standard Shaver · 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 00841626101234), received between Sep 18, 2020 and Sep 18, 2020 — 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
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
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 ↗
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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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