Vantage 351-93-01Recalls & reported problems
Exactech, Inc. · ANKLE IMPACTOR HANDLE · 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 10885862290793), received between Nov 3, 2020 and Nov 3, 2020 — 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.
Most reported problems
Device problems
- Break1
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.
MalfunctionNov 3, 2020Break; Break
AS REPORTED, IMPACTOR HANDLE BROKE OFF CONNECTION TIP TO IMPACTOR ASSEMBLY WHEN IMPACTING TIBIAL IMPLANT. NO PART OR PIECES FELL INTO THE PATIENT. CONTINUED CASE WITHOUT HANDLE AND IMPACTED WITH BROKEN ASSEMBLY DEVICE. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE DEVICE WILL BE RETURNED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10778190 ↗
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- DURALOC 2360-71-000Depuy Orthopaedics, Inc. · IMPACTOR716 reports
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- INHANCE 6205-10-103Depuy (Ireland) · IMPACTOR337 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.