TOMOFIX 397.995Recalls & reported problems
Synthes GmbH · TOMOFIX OSTEOTOMY CHISEL 25MM WIDTH · 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 10886982201300), received between Aug 27, 2024 and Aug 27, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
- Failure to Cut1
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.
MalfunctionAug 27, 2024Break; Failure to Cut; Break; Failure to Cut
IT WAS REPORTED THAT ON (B)(6) 2024 THERE WAS A DULL OSTEOTOMY'S, SPREADER DOES NOT OPEN CORRECTLY. THIS REPORT IS FOR ONE (1) TOMOFIX OSTEOTOMY CHISEL 25MM WIDTH. THIS IS REPORT 1 OF 1 FOR COMPLAINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20081396 ↗
Other CHISEL, SURGICAL, MANUAL devices
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- NA 2421-01-000Depuy (Ireland) · CHISEL, SURGICAL, MANUAL36 reports
- NA 399.56Synthes GmbH · CHISEL, SURGICAL, MANUAL11 reports
- NA 399.55Synthes GmbH · CHISEL, SURGICAL, MANUAL10 reports
- T.L.I.F. 274279000Depuy Spine, LLC · CHISEL, SURGICAL, MANUAL7 reports
- NA 332.121Synthes GmbH · CHISEL, SURGICAL, MANUAL5 reports
- NA 202953Depuy Spine, LLC · CHISEL, SURGICAL, MANUAL4 reports
- INSTRUMENT 6541-4-709Howmedica Osteonics Corp. · CHISEL, SURGICAL, MANUAL4 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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