CHS 110022Recalls & reported problems
Smith & Nephew, Inc. · AMBI INSERTION WRENCH · 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 03596010033185), received between Oct 3, 2023 and Oct 3, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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
- Fracture1
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.
MalfunctionOct 3, 2023Fracture; Fracture
IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, ONE (X1) AMBI INSERTION WRENCH WAS BROKEN. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED OR IF THERE WAS ANY DELAY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17861988 ↗
Other WRENCH devices
- MONARCH 277040510Medos International Sàrl · WRENCH199 reports
- PINNACLE 2217-50-008Depuy (Ireland) · WRENCH108 reports
- SIGMA 96-1673Depuy (Ireland) · WRENCH102 reports
- P.F.C. 86-5189Depuy (Ireland) · WRENCH92 reports
- Veptr 03.641.004Synthes GmbH · WRENCH86 reports
- RECLAIM 2975-00-300Depuy (Ireland) · WRENCH51 reports
- PINNACLE 2217-50-006Depuy (Ireland) · WRENCH34 reports
- NA 388.261Synthes GmbH · WRENCH32 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.