TOMOFIX 397.994Recalls & reported problems
Synthes GmbH · TOMOFIX OSTEOTOMY CHISEL 20MM WIDTH · Class 1
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982201294), received between Apr 8, 2019 and Mar 17, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
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
- Break2
- Contamination /Decontamination Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
- No Patient Involvement1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 17, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT THE OSTEOTOMES ARE NOT CLEANLY GROUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21619915 ↗MalfunctionJul 1, 2019Break; Break
IT WAS REPORTED THAT ON DURING ROUTINE INCOMING INSPECTION OF A LOANER SET AN UNKNOWN DATE, A TOMOFIX OSTEOTOMY CHISEL WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A TOMOFIX OSTEOTOMY CHISEL 20MM WIDTH. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 8750143 ↗MalfunctionApr 8, 2019Break; Break
IT WAS REPORTED THAT ON (B)(6) 2019, DURING A CORRECTIVE OSTEOTOMY OF A DISTAL FEMUR USING A TOMOFIX SET, THE BACK END OF THE CHISEL BROKE OFF. THE SURGEON MADE THE FIRST CUT FOR THE OSTEOTOMY USING A SAW BLADE AND THEN INSERTED THE TOMOFIX OSTEOTOMY CHISEL INTO THE CUT. HE BEGAN HITTING THE CHISEL WITH A MALLET ATTEMPTING TO COMPLETE THE OSTEOTOMY AND AFTER SEVERAL BLOWS, THE CHISEL BROKE. THERE WERE NO FRAGMENTS GENERATED FORM THE BROKEN DEVICE. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT CONSEQUENCE. CONCOMITANT MEDICAL PRODUCTS REPORTED: UNKNOWN SAW BLADE (PART # UNKNOWN, LOT# UNKNOWN, QUANTITY # 1); UNKNOWN MALLET (PART # UNKNOWN, LOT# UNKNOWN, QUANTITY # 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8493601 ↗
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- 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
- INSTRUMENT 6541-4-709Howmedica Osteonics Corp. · CHISEL, SURGICAL, MANUAL4 reports
- NA 202953Depuy Spine, LLC · CHISEL, SURGICAL, MANUAL4 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.