Vantage 351-10-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862525673), received between Nov 30, 2021 and Nov 30, 2021 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 30, 2021Break; Break

  IT WAS REPORTED THAT DURING SURGICAL USE THE ANKLE SIZER WAS PUT INTO PATIENT AND SNAPPED IN HALF. SURGEON WAS ABLE TO REMOVE THE SIZER AND CONTINUE ON WITH THE CASE. THE PATIENT WAS NOT INJURED DURING THIS CASE. THERE WAS NO SURGICAL DELAY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THIS INCIDENT DID NOT EFFECT THE OUTCOME OF THE SURGERY NOR HAVE ANY ADVERSE EFFECTS ON THE PATIENT HEALTH. (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12891627 ↗