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TOMOFIX 397.992Recalls & reported problems

Synthes GmbH · TOMOFIX OSTEOTOMY CHISEL 10MM WIDTH · Class 1

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982201270), received between Jul 1, 2019 and Mar 14, 2022 — classified as 2 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.

Most reported problems

Device problems

  • Break2

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Patient Involvement1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 14, 2022Break

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING INITIAL USE THE EDGES WERE ON SHARP SIDE AND GOT DAMAGE. THIS REPORT IS FOR ONE (1) TOMOFIX OSTEOTOMY CHISEL 10MM WIDTH. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13759504 ↗
  • MalfunctionJul 1, 2019Break; Break

    IT WAS REPORTED THAT DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET ON AN UNKNOWN DATE, THE TOMOFIX OSTEOTOMY CHISEL WAS OBSERVED BROKEN. THERE WAS NO KNOWN HOSPITAL OR PATIENT INVOLVEMENT. THIS REPORT IS FOR A TOMOFIX OSTEOTOMY CHISEL 10MM WIDTH. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Patient Involvement

    MAUDE report 8749437 ↗

Other CHISEL, SURGICAL, MANUAL devices

All CHISEL, SURGICAL, MANUAL devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.