In2Bones G01 01512Recalls & reported problems
In2bones · SHANNON BURR LG20 MM STERILE DIA 2.0 X LENGTH 75 MM · Class 1
- 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 03760225715918), received between Mar 16, 2026 and Mar 16, 2026 — classified as 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information1
- Use of Device Problem1
Patient problems
- Laceration(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 16, 2026Use of Device Problem; Insufficient Device Problem Information
THE DRILL BIT BROKE DURING THE PROCEDURE. THE FRAGMENT WAS REMOVED, AND A MINOR INJURY OCCURRED TO THE USER. BOTH PARTIES ARE DOING WELL.
Patient problems: Laceration(s)
MAUDE report 24602892 ↗
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- NA 351.27Synthes GmbH · BUR, SURGICAL, GENERAL & PLASTIC SURGERY28 reports
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- Arthrex® AR-8500FOTArthrex, Inc. · BUR, SURGICAL, GENERAL & PLASTIC SURGERY17 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.