NA 03.111.019Recalls & reported problems
Synthes GmbH · JOINT PREP/CHISEL/CURVED NARROW/10MM WIDE · 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 10886982072184), received between Feb 4, 2025 and Feb 4, 2025 — 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Material Deformation1
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.
MalfunctionFeb 4, 2025Break; Material Deformation; Break; Material Deformation
IT WAS REPORTED THAT ON AN UNKNOWN DATE, WHILE INVENTORYING SETS, IT WAS FOUND THAT THE CURVED CHISEL NARROW WAS CHIPPING. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21305753 ↗
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- 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.