IBS-B G01 N0061Recalls & reported problems
In2Bones USA, LLC · Countersink for screwsDia.3.3mm, Non-Sterile · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810021867748), received between May 8, 2025 and May 8, 2025 — classified as 1 injury.
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 8, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE SURGEON THAT THE DEVICE, G01 N0061 COUNTERSINK FOR SCREWSDIA.3.3MM, NON-STERILE, WAS USED AFTER DRILLING WHEN IT WAS REPORTED THAT THE COUNTERSINK FRACTURED INSIDE THE PATIENT. THE SURGEON MADE SEVERAL ATTEMPTS TO REMOVE THE COUNTERSINK FRAGMENTS FROM THE PATIENT WITHOUT SUCCESS. THE FRAGMENTS REMAIN INSIDE THE PATIENT WITHOUT FURTHER COMPLICATIONS.
Patient problems: Foreign Body In Patient
MAUDE report 21984681 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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