NA 698331878Recalls & reported problems
Depuy Spine, LLC · MODIFIED INSTRUMENT CHISEL 8.5mm · Class 1
- 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 10705034329918), received between Jan 8, 2019 and Jan 8, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Material Split, Cut or Torn1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 8, 2019Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED INSTRUMENT BROKE. SALES REP REPORTED TO SURGEON REQUEST TEAM. NO DETAILS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8228026 ↗
Other CHISEL, SURGICAL, MANUAL devices
- SIGMA 2024-85-000Depuy (Ireland) · CHISEL, SURGICAL, MANUAL63 reports
- 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
- 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.