RENOVATION 75100519Recalls & reported problems
Smith & Nephew, Inc. · CHISEL BLADE STRAIGHT 10X60X1MM S · Class 1
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07611996119022), received between Aug 26, 2019 and Aug 26, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Unstable” (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
- Unstable1
Patient problems
- Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 26, 2019Unstable; Unstable
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON 24/7/2019 DUE TO INSTABILITY. A ZIMMER PRODUCT WAS IMPLANTED INSTEAD. FURTHER INFORMATION WAS REQUESTED.
Patient problems: Injury
MAUDE report 8929129 ↗
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- NA 399.55Synthes GmbH · CHISEL, SURGICAL, MANUAL10 reports
- T.L.I.F. 274279000Depuy Spine, LLC · CHISEL, SURGICAL, MANUAL7 reports
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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.