NEOSYS G02 10001Recalls & reported problems
In2bones · NEOSYS SET SINGLE USE INSTRUMENTS · Class 1
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 03760225712191), received between Mar 26, 2026 and Mar 26, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Use of Device Problem” (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.
Reports received per month
Most reported problems
Device problems
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 26, 2026Use of Device Problem
DURING A MINI-OPEN CHEVRON OSTEOTOMY FOR HALLUX VALGUS, TWO STERILE, SINGLE-USE TORX 8 SCREWDRIVER BLADES (I2B IBS STERILE INSTRUMENTS - G0210001, 3.0/3.5) FRACTURED AT THE HEAD DURING THE INSERTION OF IBS SCREWS (S35ST120 AND S35ST122). ALL FRAGMENTS WERE REMOVED, AND NO METAL DEBRIS REMAINED IN THE PATIENT'S BODY. ACCORDING TO THE INFORMATION PROVIDED, THE CHAMFERING DRILL WAS NOT USED DURING SCREW INSERTION, WHICH MAY HAVE CONTRIBUTED TO THE SHAFT FRACTURES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24696766 ↗
Other Kit, Surgical Instrument, Disposable devices
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- Medline Industries, Inc. DYNJ83185AMedline Industries, Inc. · Kit, surgical instrument, disposable2 recalls0 reports
- Synergetics 18069Synergetics USA, Inc. · Kit, Surgical Instrument, Disposable2 recalls0 reports
- Medline Industries, Inc. DYNJ69761Medline Industries, Inc. · Kit, surgical instrument, disposable2 recalls0 reports
- Medline Industries, Inc. DYNJ24628MMedline Industries, Inc. · Kit, surgical instrument, disposable2 recalls0 reports
- Synergetics 18060Synergetics USA, Inc. · Kit, Surgical Instrument, Disposable2 recalls0 reports
- Synergetics 18069WSynergetics USA, Inc. · Kit, Surgical Instrument, Disposable2 recalls0 reports
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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